Trial Outcomes & Findings for Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention (NCT NCT06017479)
NCT ID: NCT06017479
Last Updated: 2024-10-09
Results Overview
Urinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of \<0.05.
COMPLETED
PHASE1/PHASE2
126 participants
4 days post-urodynamic procedure
2024-10-09
Participant Flow
Data were collected using consecutive sampling until the required number of subjects was reached. The primary data source is from patients with indications for urodynamic examination at Dr. Cipto Mangunkusumo, Siloam Asri, and Persahabatan Hospitals, starting December 30, 2022.
The inclusion criteria were any above 18-year-old who underwent UDS \& were willing to participate in this study. Patients who had at least one of these exclusion criteria were excluded: allergy to levofloxacin, history of antibiotics consumption in 1 month prior to the study, pregnancy, uncontrolled and untreated diabetes mellitus, use of urinary catheter, UTI proved through urinalysis prior to the study, and refusal to participate.
Participant milestones
| Measure |
Pre-urodynamic Fosfomycin
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
|
Pre-urodynamic Levofloxacin
Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention
Baseline characteristics by cohort
| Measure |
Pre-urodynamic Fosfomycin
n=63 Participants
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
|
Pre-urodynamic Levofloxacin
n=63 Participants
Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.99 years
STANDARD_DEVIATION 19.08 • n=99 Participants
|
42 years
STANDARD_DEVIATION 17.17 • n=107 Participants
|
52.2 years
STANDARD_DEVIATION 18.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
75 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
|
63 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
126 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 days post-urodynamic procedureUrinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of \<0.05.
Outcome measures
| Measure |
Pre-urodynamic Fosfomycin
n=63 Participants
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
|
Pre-urodynamic Levofloxacin
n=63 Participants
Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
|
|---|---|---|
|
The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms.
Diagnosed UTI
|
12 Participants
|
14 Participants
|
|
The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms.
Symptomatic UTIs
|
7 Participants
|
6 Participants
|
|
The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms.
Non UTIs
|
44 Participants
|
43 Participants
|
Adverse Events
Pre-urodynamic Fosfomycin
Pre-urodynamic Levofloxacin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-urodynamic Fosfomycin
n=63 participants at risk
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
Fosfomycin 3000 MG: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
|
Pre-urodynamic Levofloxacin
n=63 participants at risk
Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
Levofloxacin 500mg: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
|
|---|---|---|
|
Gastrointestinal disorders
Nauseous
|
4.8%
3/63 • Number of events 3 • After four days of Single Dose Fosfomycin and Single Dose Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin, Fosfomycin administration, and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure.
|
3.2%
2/63 • Number of events 2 • After four days of Single Dose Fosfomycin and Single Dose Levofloxacin administration, patients were being assessed for their clinical conditions, such as symptoms related to UTIs, and also adverse events related to Levofloxacin, Fosfomycin administration, and UDS
The adverse events were collected through direct interviews with the patients four days after the procedure.
|
Additional Information
Prof. dr. Harrina Erlianti Rahardjo, Sp.U(K), PhD
Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place