Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT) (CEF-IMPACT)

April 18, 2019 updated by: Centre Hospitalier Universitaire de Besancon

Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)

The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
  • Signed Informed Consent

Exclusion Criteria:

  • Hypersensitivity to ceftriaxone or cefotaxime, to another cephalosporin or to any of the excipients of the specialities concerned.
  • History of severe hypersensitivity (e.g., anaphylactic reaction) to another class of antibacterial agent of the beta-lactam family (penicillins, monobactams and carbapenes)
  • Subcutaneous administration of ceftriaxone
  • Pregnant and breastfeeding woman
  • Suspicion of Pseudomonas infection or documented Pseudomonas infection requiring ceftazidime treatment
  • Suspicion of group III enterobacteriaceae infection or group III enterobacteriaceae infection requiring cefepime treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefotaxime or ceftriaxone group
free use of cefotaxime or ceftriaxone by the investigator
Procedure: Rectal swab
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
Drug: Cefotaxime/ceftriaxone
ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician
Experimental: Cefotaxim group
Systematic use of cefotaxime
Procedure: Rectal swab
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
Drug: Cefotaxime Injection
Systematic use of cefotaxime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of occurrence of digestive carrying of EB C3G-R
Time Frame: 30 days after inclusion
Frequency of occurrence of digestive carrying of EB C3G-R
30 days after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of EB C3G-R infections
Time Frame: 2 years
Evaluate the effect of systematic use of cefotaxime rather than ceftriaxone on the incidence rate of EB C3G-R infections in participating departments.
2 years
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
Time Frame: 30 days after inclusion
Compare the number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), 30 days after inclusion, between patients treated with ceftriaxone and patients treated with cefotaxime.
30 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2018

Primary Completion (Anticipated)

April 3, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2016/74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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