Trials / Unknown
UnknownNCT02681263
Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Temocillin | Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-04-01
- Completion
- 2018-09-01
- First posted
- 2016-02-12
- Last updated
- 2018-06-06
Locations
19 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02681263. Inclusion in this directory is not an endorsement.