Conditions: Urinary Tract Infection
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 13
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effectiveness of antibiotic flomoxef with cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.

Detailed description:
The drug being tested in this study is called Flomoxef. Flomoxef is being tested in people with a complicated urinary tract infection (cUTI) including a kidney infection. This study compares Flomoxef to Cefepime, another antibiotic.

The study enrolled 13 patients.

Participants are randomly assigned by a computer generated number to one of two treatment groups:

* Flomoxef - intravenous infusion 2g twice daily (every 12 hours); or
* Cefepime - intravenous infusion 1g twice daily (every 12 hours).

This multi-center trial is conducted at 4 sites in the Russian Federation. The overall time to participate in this study is 30+/-3 days. Participants make six visits to the clinic.

Study was prematurely terminated due to administrative and strategic reasons.

Arms:
arm 1: Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours), for up to 12 days. arm 2: Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.

Interventions: intervention 1: Flomoxef intervention 2: Cefepime
Intervention descriptions: intervention 1: Flomoxef intravenous infusion intervention 2: Cefepime intravenous infusion

Protocol document: