Trial Outcomes & Findings for Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054) (NCT NCT00771316)
NCT ID: NCT00771316
Last Updated: 2017-03-21
Results Overview
Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.
TERMINATED
PHASE3
6 participants
5 to 9 days post therapy
2017-03-21
Participant Flow
Phase III First patient enrolled on 09-Dec-2008 Last patient enrolled on 12-May-2009 The last patient's last visit was 08-Jun-2009 The study was conducted at 6 study centers in the United States and Europe. Study was terminated early due to feasibility issues including slow enrollment.
Participant milestones
| Measure |
MK0826 (Ertapenem)
MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
|
Meropenem
Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
MK0826 (Ertapenem)
MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
|
Meropenem
Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Patient withdrew consent
|
1
|
0
|
|
Overall Study
Discontinued due to early termination
|
1
|
0
|
Baseline Characteristics
Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
Baseline characteristics by cohort
| Measure |
MK0826 (Ertapenem)
n=4 Participants
MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
|
Meropenem
n=2 Participants
Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.75 years
n=99 Participants
|
58 years
n=107 Participants
|
44.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 to 9 days post therapyPopulation: This analysis was not completed due to early termination of the study.
Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After at least 4 days of IV therapyPopulation: This analysis was not completed due to early termination of the study.
Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After at least 4 days of IV therapyPopulation: This analysis was not completed due to early termination of the study.
Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.
Outcome measures
Outcome data not reported
Adverse Events
MK0826 (Ertapenem)
Meropenem
Serious adverse events
| Measure |
MK0826 (Ertapenem)
n=4 participants at risk
MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
|
Meropenem
n=2 participants at risk
Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
|
|---|---|---|
|
General disorders
Shortness of breath
|
0.00%
0/4 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
50.0%
1/2 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
50.0%
1/2 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
Other adverse events
| Measure |
MK0826 (Ertapenem)
n=4 participants at risk
MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
|
Meropenem
n=2 participants at risk
Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
|
|---|---|---|
|
Gastrointestinal disorders
Mouth dryness
|
25.0%
1/4 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
0.00%
0/2 • Any serious adverse experience, including death due to any cause, which occurred to any subject entered in the study or within 14 days following cessation of treatment.
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER