Trial Outcomes & Findings for PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults (NCT NCT02570074)
NCT ID: NCT02570074
Last Updated: 2019-07-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
3 months
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Fosfomycin - 3 Doses QoD/7 Doses QD
Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.
Fosfomycin: Broad spectrum antibiotic
|
Fosfomycin - 7 Doses QD/3 Doses QoD
Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.
Fosfomycin: Broad spectrum antibiotic
|
|---|---|---|
|
Period 1 (First Dosing Regimen)
STARTED
|
9
|
10
|
|
Period 1 (First Dosing Regimen)
COMPLETED
|
9
|
10
|
|
Period 1 (First Dosing Regimen)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Second Dosing Regimen)
STARTED
|
9
|
10
|
|
Period 2 (Second Dosing Regimen)
COMPLETED
|
8
|
10
|
|
Period 2 (Second Dosing Regimen)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fosfomycin - 3 Doses QoD/7 Doses QD
Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.
Fosfomycin: Broad spectrum antibiotic
|
Fosfomycin - 7 Doses QD/3 Doses QoD
Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.
Fosfomycin: Broad spectrum antibiotic
|
|---|---|---|
|
Period 2 (Second Dosing Regimen)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Fosfomycin - 3 Doses QoD/7 Doses QD
n=9 Participants
Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.
Fosfomycin: Broad spectrum antibiotic
|
Fosfomycin - 7 Doses QD/3 Doses QoD
n=10 Participants
Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.
Fosfomycin: Broad spectrum antibiotic
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=99 Participants
|
27 years
n=107 Participants
|
27 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Weight
|
75.3 kilogram
STANDARD_DEVIATION 12.3 • n=99 Participants
|
76.0 kilogram
STANDARD_DEVIATION 10.9 • n=107 Participants
|
75.7 kilogram
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Entry site - University of Illinois Chicago
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Height
|
173.2 centimeter
STANDARD_DEVIATION 12.0 • n=99 Participants
|
173.8 centimeter
STANDARD_DEVIATION 7.9 • n=107 Participants
|
173.6 centimeter
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
BMI
|
25.0 kg/m^2
STANDARD_DEVIATION 2.5 • n=99 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 2.4 • n=107 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Estimated creatinine clearance
|
105.0 mL/min
STANDARD_DEVIATION 14.6 • n=99 Participants
|
113.7 mL/min
STANDARD_DEVIATION 23.0 • n=107 Participants
|
109.6 mL/min
STANDARD_DEVIATION 19.4 • n=206 Participants
|
|
QTC Interval
|
402.8 milliseconds
STANDARD_DEVIATION 19.7 • n=99 Participants
|
405.2 milliseconds
STANDARD_DEVIATION 17.2 • n=107 Participants
|
404.1 milliseconds
STANDARD_DEVIATION 17.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Number (%) of Grade 2 or Higher AEs Regardless of Relationship to Study Drug
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dosePopulation: Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.
Day 1 mean and standard deviation plasma concentrations \[mg/L\] at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Day 1: Plasma PK Concentrations [mg/L]
0 hours
|
0.08 mg/L
Standard Deviation 0.36
|
0 mg/L
Standard Deviation 0
|
|
Day 1: Plasma PK Concentrations [mg/L]
1 hour
|
16.61 mg/L
Standard Deviation 5.44
|
15.90 mg/L
Standard Deviation 6.70
|
|
Day 1: Plasma PK Concentrations [mg/L]
1.5 hours
|
22.20 mg/L
Standard Deviation 7.98
|
21.35 mg/L
Standard Deviation 7.17
|
|
Day 1: Plasma PK Concentrations [mg/L]
2 hours
|
23.36 mg/L
Standard Deviation 7.04
|
22.12 mg/L
Standard Deviation 6.34
|
|
Day 1: Plasma PK Concentrations [mg/L]
3 hours
|
18.72 mg/L
Standard Deviation 5.13
|
17.86 mg/L
Standard Deviation 4.67
|
|
Day 1: Plasma PK Concentrations [mg/L]
4 hours
|
14.08 mg/L
Standard Deviation 4.00
|
13.53 mg/L
Standard Deviation 3.87
|
|
Day 1: Plasma PK Concentrations [mg/L]
6 hours
|
9.11 mg/L
Standard Deviation 2.38
|
8.43 mg/L
Standard Deviation 2.38
|
|
Day 1: Plasma PK Concentrations [mg/L]
8 hours
|
6.08 mg/L
Standard Deviation 1.48
|
5.69 mg/L
Standard Deviation 1.57
|
|
Day 1: Plasma PK Concentrations [mg/L]
12 hours
|
3.43 mg/L
Standard Deviation 1.01
|
3.19 mg/L
Standard Deviation 1.28
|
|
Day 1: Plasma PK Concentrations [mg/L]
24 hours
|
0.88 mg/L
Standard Deviation 0.59
|
1.33 mg/L
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: Day 5: 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dosePopulation: Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.
Day 5 mean and standard deviation plasma concentrations \[mg/L\] at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Day 5: Plasma PK Concentrations [mg/L]
0 hours
|
0.23 mg/L
Standard Deviation 0.37
|
1.33 mg/L
Standard Deviation 1.12
|
|
Day 5: Plasma PK Concentrations [mg/L]
1 hour
|
16.29 mg/L
Standard Deviation 6.23
|
16.81 mg/L
Standard Deviation 4.27
|
|
Day 5: Plasma PK Concentrations [mg/L]
1.5 hours
|
21.21 mg/L
Standard Deviation 6.91
|
22.07 mg/L
Standard Deviation 5.02
|
|
Day 5: Plasma PK Concentrations [mg/L]
2 hours
|
22.48 mg/L
Standard Deviation 6.44
|
23.37 mg/L
Standard Deviation 5.71
|
|
Day 5: Plasma PK Concentrations [mg/L]
3 hours
|
19.38 mg/L
Standard Deviation 5.34
|
19.45 mg/L
Standard Deviation 5.10
|
|
Day 5: Plasma PK Concentrations [mg/L]
4 hours
|
14.98 mg/L
Standard Deviation 4.82
|
15.12 mg/L
Standard Deviation 4.27
|
|
Day 5: Plasma PK Concentrations [mg/L]
6 hours
|
9.78 mg/L
Standard Deviation 3.08
|
9.91 mg/L
Standard Deviation 2.74
|
|
Day 5: Plasma PK Concentrations [mg/L]
8 hours
|
6.47 mg/L
Standard Deviation 1.95
|
6.93 mg/L
Standard Deviation 1.96
|
|
Day 5: Plasma PK Concentrations [mg/L]
12 hours
|
3.71 mg/L
Standard Deviation 1.31
|
4.02 mg/L
Standard Deviation 1.61
|
|
Day 5: Plasma PK Concentrations [mg/L]
24 hours
|
0.82 mg/L
Standard Deviation 0.40
|
1.12 mg/L
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.
To estimate the fosfomycin pharmacokinetic parameter maximum plasma concentration (Cmax) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
Day 1
|
23.79 mg/L
Standard Deviation 7.48
|
23.47 mg/L
Standard Deviation 6.62
|
|
Maximum Plasma Concentration (Cmax)
Day 5
|
24.41 mg/L
Standard Deviation 6.23
|
23.75 mg/L
Standard Deviation 5.61
|
PRIMARY outcome
Timeframe: 24 hoursTo estimate the fosfomycin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC 0-infinity) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Day 1: Area Under the Concentration Time Curve (AUC 0-infinity)
|
148.57 mg*hour/L
Standard Deviation 35.57
|
176.44 mg*hour/L
Standard Deviation 176.96
|
PRIMARY outcome
Timeframe: 24 hoursTo estimate the fosfomycin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC 0-tau) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Day 5: Area Under the Concentration Time Curve (AUC Tau-infinity)
|
151.60 mg*hours/L
Standard Deviation 35.61
|
156.62 mg*hours/L
Standard Deviation 42.52
|
PRIMARY outcome
Timeframe: Dosing period: 7 daysOutcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Number of Subjects Who Prematurely Discontinue Study Drug
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pooled over 24 hours: Day 1Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Total Body Clearance (CL)
|
21.62 L/h
Standard Deviation 6.79
|
21.96 L/h
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Pooled over 24 hours at Day 1 and Day 5Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Apparent Volume of Distribution (Vss)
Day 1
|
172.25 L
Standard Deviation 70.41
|
143.97 L
Standard Deviation 55.31
|
|
Apparent Volume of Distribution (Vss)
Day 5
|
140.57 L
Standard Deviation 67.94
|
146.68 L
Standard Deviation 67.64
|
SECONDARY outcome
Timeframe: Pooled over 24 hours at Day 1 and Day 5Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Elimination Rate Constant (z)
Day 1
|
0.13 1/h
Standard Deviation 0.04
|
0.17 1/h
Standard Deviation 0.06
|
|
Elimination Rate Constant (z)
Day 5
|
0.16 1/h
Standard Deviation 0.04
|
0.16 1/h
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Pooled over 24 hours at Day 1 and Day 5Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Elimination Half-life (t½)
Day 1
|
5.56 h
Standard Deviation 1.54
|
5.90 h
Standard Deviation 7.16
|
|
Elimination Half-life (t½)
Day 5
|
7.53 h
Standard Deviation 4.09
|
7.31 h
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Pooled over 24 hours at Day 1 and Day 5Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Renal Clearance (CLR)
Day 5
|
7.53 L/h
Standard Deviation 4.09
|
7.31 L/h
Standard Deviation 3.46
|
|
Renal Clearance (CLR)
Day 1
|
7.10 L/h
Standard Deviation 3.64
|
8.09 L/h
Standard Deviation 5.60
|
SECONDARY outcome
Timeframe: Pooled over 24 hours at Day 1 and Day 5Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Amount Excreted in the Urine (Ae)
Day 1
|
1047.05 mg
Standard Deviation 710.53
|
1102.34 mg
Standard Deviation 772.67
|
|
Amount Excreted in the Urine (Ae)
Day 5
|
1177.24 mg
Standard Deviation 790.76
|
1161.57 mg
Standard Deviation 718.09
|
SECONDARY outcome
Timeframe: 3 monthsUBT for E.coli ATCC 25922
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
8 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 1, 4 to 8 hr
|
8 Reciprocal Titers
Interval 2.0 to 32.0
|
4.5 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 1, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
3 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 1, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
6 Reciprocal Titers
Interval 2.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 5, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 5, 4 to 8 hr
|
12 Reciprocal Titers
Interval 1.0 to 32.0
|
12 Reciprocal Titers
Interval 1.0 to 32.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 5, 8 to 12 hr
|
6 Reciprocal Titers
Interval 1.0 to 16.0
|
6 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922
Day 5, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: 24 hoursUrine Fosfomycin concentrations \[mg/L\]
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urine Fosfomycin Concentrations [mg/L]
Pre-dose
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
|
Urine Fosfomycin Concentrations [mg/L]
0-4 hours post-Dose
|
471.71 mg/L
Standard Deviation 423.10
|
563.55 mg/L
Standard Deviation 665.94
|
|
Urine Fosfomycin Concentrations [mg/L]
4-8 hours post-dose
|
584.23 mg/L
Standard Deviation 348.46
|
402.90 mg/L
Standard Deviation 367.31
|
|
Urine Fosfomycin Concentrations [mg/L]
8-12 hours post dose
|
201.99 mg/L
Standard Deviation 119.22
|
228.13 mg/L
Standard Deviation 163.30
|
|
Urine Fosfomycin Concentrations [mg/L]
12-24 hours post dose
|
202.73 mg/L
Standard Deviation 149.08
|
175.13 mg/L
Standard Deviation 102.21
|
SECONDARY outcome
Timeframe: 24 hours at Day 1 and Day 5For pathogens E. coli ATCC 25922, E. coli ATCC BAA-2323, K. pneumoniae ATCC 33495, K. pneumoniae ATCC 700603 and P. mirabilis ATCC 35659
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
UBT-time Curve (AUBT24)
E. coli ATCC 25922, Day 1
|
175.37 titers * hours
Standard Deviation 174.30
|
158.67 titers * hours
Standard Deviation 199.12
|
|
UBT-time Curve (AUBT24)
E. coli ATCC 25922, Day 5
|
202.53 titers * hours
Standard Deviation 218.71
|
196.67 titers * hours
Standard Deviation 214.84
|
|
UBT-time Curve (AUBT24)
E. coli ATCC BAA-2323, Day 1
|
139.47 titers * hours
Standard Deviation 140.45
|
121.56 titers * hours
Standard Deviation 145.88
|
|
UBT-time Curve (AUBT24)
E. coli ATCC BAA-2323, Day 5
|
198.84 titers * hours
Standard Deviation 219.90
|
156.33 titers * hours
Standard Deviation 172.96
|
|
UBT-time Curve (AUBT24)
K. pneumoniae ATCC 33495, Day 1
|
15.68 titers * hours
Standard Deviation 17.75
|
11.67 titers * hours
Standard Deviation 11.95
|
|
UBT-time Curve (AUBT24)
K. pneumoniae ATCC 33495, Day 5
|
20.63 titers * hours
Standard Deviation 19.11
|
17.44 titers * hours
Standard Deviation 16.13
|
|
UBT-time Curve (AUBT24)
K. pneumoniae ATCC 700603, Day 1
|
10.32 titers * hours
Standard Deviation 8.23
|
4.56 titers * hours
Standard Deviation 7.02
|
|
UBT-time Curve (AUBT24)
K. pneumoniae ATCC 700603, Day 5
|
12.42 titers * hours
Standard Deviation 8.83
|
9.89 titers * hours
Standard Deviation 6.74
|
|
UBT-time Curve (AUBT24)
P. Mirabilis ATCC 35659, Day 1
|
96.53 titers * hours
Standard Deviation 135.80
|
53.78 titers * hours
Standard Deviation 70.75
|
|
UBT-time Curve (AUBT24)
P. Mirabilis ATCC 35659, Day 5
|
96.95 titers * hours
Standard Deviation 148.42
|
90.33 titers * hours
Standard Deviation 146.85
|
SECONDARY outcome
Timeframe: Day 5: 24 hoursUrine Fosfomycin concentrations \[mg/L\]
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urine Fosfomycin Concentrations [mg/L]
Pre-dose
|
66.24 mg/L
Standard Deviation 102.59
|
314.34 mg/L
Standard Deviation 257.97
|
|
Urine Fosfomycin Concentrations [mg/L]
0-4 hours post-Dose
|
642.83 mg/L
Standard Deviation 521.45
|
465.74 mg/L
Standard Deviation 266.24
|
|
Urine Fosfomycin Concentrations [mg/L]
4-8 hours post-dose
|
643.93 mg/L
Standard Deviation 496.86
|
608.99 mg/L
Standard Deviation 344.54
|
|
Urine Fosfomycin Concentrations [mg/L]
8-12 hours post dose
|
295.01 mg/L
Standard Deviation 272.97
|
254.75 mg/L
Standard Deviation 120.71
|
|
Urine Fosfomycin Concentrations [mg/L]
12-24 hours post dose
|
169.51 mg/L
Standard Deviation 112.14
|
222.20 mg/L
Standard Deviation 167.87
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UBT for E. Coli ATCC BAA-2323
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 1, 4 to 8 hr
|
8 Reciprocal Titers
Interval 2.0 to 16.0
|
2.5 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
8 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 1, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
3 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 1, 12 to 24 hr
|
2 Reciprocal Titers
Interval 1.0 to 4.0
|
4 Reciprocal Titers
Interval 2.0 to 4.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 5, >0 to 4 hr
|
16 Reciprocal Titers
Interval 4.0 to 32.0
|
4 Reciprocal Titers
Interval 2.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 5, 4 to 8 hr
|
8 Reciprocal Titers
Interval 0.0 to 32.0
|
16 Reciprocal Titers
Interval 4.0 to 32.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 5, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323
Day 5, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 4.0
|
4 Reciprocal Titers
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UBT for E.coli K. Pneumoniae ATCC 33495
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 1, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 1, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 1, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 1, 4 to 8 hr
|
2 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 5, >0 to 4 hr
|
2 Reciprocal Titers
Interval 0.0 to 4.0
|
1.5 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 5, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
2 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 5, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495
Day 5, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
1.0 Reciprocal Titers
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UBT for K. Pneumoniae ATCC 700603
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 1, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 1, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 1, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 1, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 5, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 5, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 5, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603
Day 5, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UBT for P. Mirabilis ATCC 35659
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 5, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 5, 4 to 8 hr
|
2 Reciprocal Titers
Interval 0.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 5, 8 to 12 hr
|
2 Reciprocal Titers
Interval 0.0 to 8.0
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 5, 12 to 24 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
2 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
2.5 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 1, 4 to 8 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
0.5 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 1, 8 to 12 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659
Day 1, 12 to 24 hr
|
1 Reciprocal Titers
Interval 1.0 to 4.0
|
2 Reciprocal Titers
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UIT for E.coli ATCC 25922
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
8 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 1, 4 to 8 hr
|
8 Reciprocal Titers
Interval 2.0 to 32.0
|
4.5 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 1, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
3 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 1, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
6 Reciprocal Titers
Interval 2.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 5, >0 to 4 hr
|
8 Reciprocal Titers
Interval 4.0 to 32.0
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 5, 4 to 8 hr
|
16 Reciprocal Titers
Interval 0.0 to 32.0
|
12 Reciprocal Titers
Interval 1.0 to 32.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 5, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
6 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922
Day 5, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UIT for E. Coli ATCC BAA-2323
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
8 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 1, 4 to 8 hr
|
8 Reciprocal Titers
Interval 2.0 to 16.0
|
2.5 Reciprocal Titers
Interval 0.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 1, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
3 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 1, 12 to 24 hr
|
2 Reciprocal Titers
Interval 1.0 to 4.0
|
4 Reciprocal Titers
Interval 2.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 5, >0 to 4 hr
|
16 Reciprocal Titers
Interval 4.0 to 32.0
|
4 Reciprocal Titers
Interval 2.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 5, 4 to 8 hr
|
8 Reciprocal Titers
Interval 0.0 to 32.0
|
16 Reciprocal Titers
Interval 4.0 to 32.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 5, 8 to 12 hr
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323
Day 5, 12 to 24 hr
|
4 Reciprocal Titers
Interval 1.0 to 4.0
|
4 Reciprocal Titers
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UIT for E.coli K. Pneumoniae ATCC 33495
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 1, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 1, 4 to 8 hr
|
2 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 1, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
0 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 1, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 5, >0 to 4 hr
|
2 Reciprocal Titers
Interval 0.0 to 4.0
|
1.5 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 5, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
2 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 5, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495
Day 5, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
1 Reciprocal Titers
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UIT for K. Pneumoniae ATCC 700603
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 1, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 1, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 1, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 1, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 5, >0 to 4 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 5, 4 to 8 hr
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
1 Reciprocal Titers
Interval 0.0 to 2.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 5, 8 to 12 hr
|
0 Reciprocal Titers
Interval 0.0 to 1.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
|
Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603
Day 5, 12 to 24 hr
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
0 Reciprocal Titers
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 hours on Day 1 and Day 5UIT for P. Mirabilis ATCC 35659
Outcome measures
| Measure |
Fosfomycin - 3 Doses QoD Regimen
n=19 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
Fosfomycin - 7 Doses QD Regimen
n=18 Participants
The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
|
|---|---|---|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 1, 8 to 12 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 1, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
2.5 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 1, 4 to 8 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
0.5 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 1, 12 to 24 hr
|
1 Reciprocal Titers
Interval 1.0 to 4.0
|
2 Reciprocal Titers
Interval 1.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 5, >0 to 4 hr
|
4 Reciprocal Titers
Interval 1.0 to 8.0
|
4 Reciprocal Titers
Interval 0.0 to 8.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 5, 4 to 8 hr
|
2 Reciprocal Titers
Interval 0.0 to 8.0
|
4 Reciprocal Titers
Interval 1.0 to 16.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 5, 8 to 12 hr
|
2 Reciprocal Titers
Interval 0.0 to 8.0
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
|
Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659
Day 5, 12 to 24 hr
|
1 Reciprocal Titers
Interval 0.0 to 4.0
|
2 Reciprocal Titers
Interval 0.0 to 2.0
|
Adverse Events
Fosfomycin - 3 Doses QoD
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Fosfomycin - 7 Doses QD
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosfomycin - 3 Doses QoD
n=19 participants at risk
Fosfomycin given as a 3 gm dose, every other day for 3 doses
Fosfomycin: Broad spectrum antibiotic
|
Fosfomycin - 7 Doses QD
n=18 participants at risk
Fosfomycin given as a 3 gm dose, once a day for 7 doses
Fosfomycin: Broad spectrum antibiotic
|
|---|---|---|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Investigations
Transaminases increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
Other adverse events
| Measure |
Fosfomycin - 3 Doses QoD
n=19 participants at risk
Fosfomycin given as a 3 gm dose, every other day for 3 doses
Fosfomycin: Broad spectrum antibiotic
|
Fosfomycin - 7 Doses QD
n=18 participants at risk
Fosfomycin given as a 3 gm dose, once a day for 7 doses
Fosfomycin: Broad spectrum antibiotic
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected though 60 days following the final study visit
|
16.7%
3/18 • Number of events 3 • Adverse event data were collected though 60 days following the final study visit
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Gastrointestinal disorders
Diarrhoea
|
78.9%
15/19 • Number of events 15 • Adverse event data were collected though 60 days following the final study visit
|
88.9%
16/18 • Number of events 16 • Adverse event data were collected though 60 days following the final study visit
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
16.7%
3/18 • Number of events 3 • Adverse event data were collected though 60 days following the final study visit
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
0.00%
0/18 • Adverse event data were collected though 60 days following the final study visit
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • Adverse event data were collected though 60 days following the final study visit
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected though 60 days following the final study visit
|
Additional Information
Keith A. Rodvold, PharmD, FCCP, FIDSA
University of Illinois at Chicago
Phone: 312-996-3341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place