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

Overview

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

Full Title of Study: “Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 3, 2020

Interventions

  • Drug: Cefotaxime Injection
    • 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/ceftriaxone
    • ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician

Arms, Groups and Cohorts

  • Active Comparator: Cefotaxime or ceftriaxone group
    • free use of cefotaxime or ceftriaxone by the investigator
  • Experimental: Cefotaxim group
    • Systematic use of cefotaxime

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Besancon
  • Provider of Information About this Clinical Study
    • Sponsor

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