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

Phase 4

• Conditions: Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
• Interventions: Procedure: Rectal swab; Drug: Cefotaxime Injection; Drug: Cefotaxime/ceftriaxone

• Registration Number: NCT03922919
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-03
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22
• Primary Completion: 2020-04-03
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cefotaxime or ceftriaxone group	Rectal swab	free use of cefotaxime or ceftriaxone by the investigator
Cefotaxime or ceftriaxone group	Cefotaxime/ceftriaxone	free use of cefotaxime or ceftriaxone by the investigator
Cefotaxim group	Cefotaxime Injection	Systematic use of cefotaxime
Cefotaxim group	Rectal swab	Systematic use of cefotaxime

Primary Outcome Measures

Name	Time	Method
Frequency of occurrence of digestive carrying of EB C3G-R	30 days after inclusion	Frequency of occurrence of digestive carrying of EB C3G-R

Secondary Outcome Measures

Name	Time	Method
incidence rate of EB C3G-R infections	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.
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)	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.

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France