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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03922919
Acronym
CEF-IMPACT
Enrollment
250
Registered
2019-04-22
Start date
2018-04-03
Completion date
2020-10-31
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)

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

Interventions

DRUGCefotaxime Injection

Systematic use of cefotaxime.

PROCEDURERectal swab

Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion

DRUGCefotaxime/ceftriaxone

ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

stepped-wedge design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of occurrence of digestive carrying of EB C3G-R30 days after inclusionFrequency of occurrence of digestive carrying of EB C3G-R

Secondary

MeasureTime frameDescription
incidence rate of EB C3G-R infections2 yearsEvaluate 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 inclusionCompare 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026