NCT02959957

Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections

A Randomized, Controlled, Multicentre Trial of Collateral Damage on the Intestinal Microbiota Inferred by Temocillin Versus Cefotaxime in Patients Receiving Empirical Treatment for Febrile Urinary Tract Infections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Håkan Hanberger · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.

Detailed description

Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria. Temocillin is approved and marketed in a few European countries since the 1980´s but not in Sweden. The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication. The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy. The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Temocillin	Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial temocillin administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.
DRUG	Cefotaxime	Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial cefotaxime administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.

Timeline

• Start date: 2016-05-20
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-11-09
• Last updated: 2019-09-16

Locations

12 sites across 1 country: Sweden