Deescalating Carbapenems in Hospital Setting

NCT02265445 | Terminated Phase 4

• 2 other identifiers: P130949AOM 13063
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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 infections (usual sites of infections and non severe infections).

Conditions

Urinary Infection; Digestive Infection; Biliary Infection; Expanded-spectrum Beta-lactamase Producing ESBL

Keywords

Carbapenems therapy/ESBL infections/Deescalation; due to ESBL-PE

Outcome Measures

Primary Outcomes (1)

• Clinical response

  The main outcome will be the favorable response defined by criteria adapted to site of infection including clinical cure with resolution of sepsis, survival, microbiological eradication either documented or suspected, and the absence of a new antibiotic course for the treatment of the same ESBL-PE) at day 7 after the end of therapy.

  7 days after the end of therapy

Secondary Outcomes (2)

• Vital status of patients

  60 days after the initiation of therapy

• absence of relapse of the infection due to the same ESBL-PE strain

  60 days after the initiation of therapy

Study Arms (2)

Maintaining carbapenem therapy

ACTIVE COMPARATOR

Intravenous therapy, Maintaining carbapenem therapy

Drug: Maintaining carbapenem therapy

Deescalation therapy

ACTIVE COMPARATOR

Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE. Deescalation therapy

Drug: Deescalation therapy

Interventions

Deescalation therapy DRUG

Intravenous therapy Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE.

Also known as: Switch for a narrow spectrum beta-lactam active

Deescalation therapy

Maintaining carbapenem therapy DRUG

Intravenous therapy, Maintaining carbapenem therapy

Maintaining carbapenem therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Urinary Tract Infections; Cholangitis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Phillipe LESPRIT, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 16, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02