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

Study Overview
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Brief Summary
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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

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

Conditions
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Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)

Intervention / Treatment
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* Drug: Cefotaxime Injection
* Procedure: Rectal swab
* Drug: Cefotaxime/ceftriaxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: stepped-wedge design
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of occurrence of digestive carrying of EB C3G-R | 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 | 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) | 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 |