Overview

Deescalating Carbapenems in Hospital Setting

Status:
Terminated
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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 infections (usual sites of infections and non severe infections).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
beta-Lactams
Lactams
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)