.A.

Not Applicable

• Conditions: -N30; N30

• Registration Number: PER-002-96
• Lead Sponsor: ABORATORIOS BAGO DEL PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1996-02-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 <38°C, absence of spontaneous lumbar pain, and absence of systemic toxicity.
- Urine leukocyte count ≥10 leukocytes/mm3 or >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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified