Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)
CEF-IMPACT
1 other identifier
interventional
250
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2018
CompletedFirst Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedApril 22, 2019
February 1, 2019
2 years
February 21, 2019
April 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
incidence rate of EB C3G-R infections
2 years
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
30 days after inclusion
Study Arms (2)
Cefotaxime or ceftriaxone group
ACTIVE COMPARATORfree use of cefotaxime or ceftriaxone by the investigator
Cefotaxim group
EXPERIMENTALSystematic use of cefotaxime
Interventions
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
- Signed Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Besançon
Besançon, 25000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2019
First Posted
April 22, 2019
Study Start
April 3, 2018
Primary Completion
April 3, 2020
Study Completion
October 1, 2020
Last Updated
April 22, 2019
Record last verified: 2019-02