None listed
Conditions
Interventions
Ampicillin-Sulbactam Group Type of group
On a daily basis, participants will receive during 3-5 days:
First dose: Ampicillin 220mg - sulbactam 147mg.
Second dose: placebo
Third dose: Ampicillin 220mg - sulbactam 147mg.
Group name:Amoxicillin-Sulbactam Group Type of group
On a daily basis, participants will receive during 3-5 days:
First dose: Amoxicillin 250mg - sulbactam 250mg.
Second dose: Amoxicillin 250mg - sulbactam 250mg.
Third dose: Amoxicillin 250mg - sulbactam 250mg.
Sponsors
LABORATORIOS BAGO DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: - Female patients, 18-50 years-old, who have provided written or verbal informed consent. - Symptoms and signs of uncomplicated low UTI: dysuria, frequent or urgent urination, less than 5 days of symptoms, body temperature 5 leukocytes at 400x. - Significant bacteriuria defined as a urine culture with >10^5CFU/ml. - The isolated bacteria must be sensitive to both antibiotics. The susceptibility test will be determined in-vitro by the diffusion test with sensitivity discs.
Exclusion criteria
Exclusion criteria: - Failure to meet all inclusion criteria. - Any antibiotic therapy in the previous 15 days. - Any of the following conditions: renal lithiasis, ureteral or urethral stenosis, neurogenic bladder, catheterization or bladder instrumentation in the last 15 days, congenital abnormalities of the kidney or ureter, recurrent chronic UTI. - Pregnancy or breastfeeding. - Prior evidence of allergy to beta-lactams. - Documented renal failure (creatinine> 2.5mg / dl). - Documented liver failure. - Any acquired immunodeficiency, systemic disease or other immunosuppressive condition (eg cancer, diabetes mellitus, connective tissue diseases). - Require simultaneous treatment with other antibiotics. - Prior to the study a microbiologic evidence that the causative pathogen is resistant to any of the investigational medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of participants that meet the following definitions: - Failure (persistence of the original pathogen with a count >10^3 CFU/ml in urine culture on day 3 or 7). - Eradication (count ≤10^3 CFU/ml or negative urine culture on day 7). - Relapse (count ≤10^3 CFU/ml or negative urine culture on day 3 but >10^3 CFU/ml on day 7). - Reinfection (count ≤10^3 CFU/ml or negative urine culture on day 3 but >10^3 CFU/ml on day 7 with a different pathogen). Measure:Bacteriological efficacy Timepoints:Days 3 and 7 as mentioned previously ; Outcome name:CLINICAL CURE: Symptoms and clinical signs disappear completely in the evaluation at the end of treatment (7 ± 2 days post-treatment). CLINICAL IMPROVEMENT: Symptoms and clinical signs decrease but do not disappear completely in the evaluation at the end of treatment (7 ± 2 days post-treatment). CLINICAL FAILURE: Symptoms and clinical signs persist in the evaluation in treatment (day 3). There is no apparent response to therapy. If bacteriological failure is demonstrated, an alternative antibiotic treatment may be initiated. NOT EVALUABLE: It is not possible to make a definitive judgment of cure, improvement or clinical failure due to reasons such as: initiation of concomitant therapy, therapy discontinued due to adverse effects, inadequate dose or non-compliance with the duration of treatment due to poor compliance, etc. CLINICAL RECHARGE: There is recurrence of symptoms and signs of UTI in the follow-up evaluation (5 ± 1 week’s post-treatment), after having obtained a cure or clinical improvement. There is recurrence of symptoms and signs of UTI in the final evaluation of the treatment (7 ± 1 day’s post-treatment), after having totally or partially given the symptoms in the evaluation during treatment (day 3). Measure:Clinical efficacy Timepoints:Days 3 and 7, week 5 as mentioned previously | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:- Failure to comply with 80% of the assigned treatment. - Failure to comply with the medication during the first two days of treatment. - Failure to take 2 successive doses of the assigned medication during any time of therapy. Measure:Adherence assessment Timepoints:At any time of therapy | — |
Countries
Peru
Outcome results
None listed