Status:
TERMINATED
Deescalating Carbapenems in Hospital Setting
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Urinary Infection
Digestive Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infec...
Detailed Description
Carbapenems are considered the antibiotics of choice for the treatment of infections due to expanded-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-PE). Their use is readily increasing bec...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Hospitalization in conventional ward; (3) Receiving a curative treatment with a carbapenem for at least 24 hours and less than 3 days for a recent infection due to an ESBL-PE, either initially or secondary documented
- With a site of infection originating from the urinary, digestive or biliary tract
- Identification of an ESBL-PE for which susceptibility results (by the method of discs) have shown to be susceptible to more narrow spectrum beta-lactams (cephalosporins, b-lactamase inhibitors, monobactams)
- With sepsis signs and symptoms controlled after initiation of antibiotic therapy
- For a community-acquired or hospital-acquired infection.
Exclusion
- Pregnancy or breastfeeding
- Neutropenia (PNN \< 500/mm3)
- Hospitalization in intensive care unit or bone marrow transplant unit
- Documented polymicrobial infection
- Culture of an ESBL-PE susceptible to an orally active drug (such as fluoroquinolones, cotrimoxazole) and possible use of one of these drugs
- Need to treat a EBLSE infection(s) wtih more than drug other than carbapenems
- Need to maintain an association with an aminoglycoside
- Colonization without signs and symptoms of sepsis
- Sepsis signs and symptoms not controlled at the time of enrolment
- Known allergy to beta-lactams
- Failure to complete medical examination
- Absence of signed written consent.
- Patient without healthcare insurance (French social security, CMU or AME)
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02265445
Start Date
June 1 2015
End Date
June 1 2016
Last Update
February 23 2017
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