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Controling Intestinal Colonization of High Risk Patients With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae (ESBL-E) - A Randomized Trial (CLEAR)
Rapid and rational health-care interventions are of great importance to efficiently combat the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a global level has been observed. For ESBL-E, effective eradication regimens are not yet available. The current study therefore aims to assess a new approach to ESBL-E eradication. To avoid administration of the eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study population will be restricted to immunocompromised high-risk patients.
Details
| Lead sponsor | Maria J.G.T. Vehreschild |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | TERMINATED |
| Enrolment | 29 |
| Start date | 2014-01 |
| Completion | 2016-12 |
Conditions
- Cancer
Interventions
- ESBL eradication regimen
- Placebo ESBL eradication
Primary outcomes
- Short-term intestinal eradication — 11 days
Short-term intestinal eradication, defined as a fecal sample , negative for ESBL-E on day 6+/-1 and day 11+/-2
Countries
Germany