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

Centre Hospitalier Universitaire de Besancon

Status and phase: Unknown; Phase 4

Conditions: Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)

Treatments: Drug: Cefotaxime/ceftriaxone; Procedure: Rectal swab; Drug: Cefotaxime Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03922919

API/2016/74

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Cefotaxime or ceftriaxone group

Active Comparator group

Description:

free use of cefotaxime or ceftriaxone by the investigator

Treatment:

Drug: Cefotaxime/ceftriaxone

Procedure: Rectal swab

Cefotaxim group

Experimental group

Description:

Systematic use of cefotaxime

Treatment:

Procedure: Rectal swab

Drug: Cefotaxime Injection