A double-blind and comparative clinical trial of the efficacy, tolerance and safety of amoxicillin-sulbactam and ampicillin-sulbactam for the treatment of patients with uncomplicated low urinary tract infection

ABORATORIOS BAGO DEL PERU S.A.,0 个研究点目标入组 0 人开始时间: 1996年2月26日最近更新: 2023年9月4日

适应症

试验速览

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•- 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.

•- 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.

发起方

ABORATORIOS BAGO DEL PERU S.A.,