Back to resultsEffect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT) (CEF-IMPACT)
Primary Purpose
Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Cefotaxime Injection
Rectal swab
Cefotaxime/ceftriaxone
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
Eligibility Criteria
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
Sites / Locations
- CHU de BesançonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cefotaxime or ceftriaxone group
Cefotaxim group
Arm Description
free use of cefotaxime or ceftriaxone by the investigator
Systematic use of cefotaxime
Outcomes
Primary Outcome Measures
Frequency of occurrence of digestive carrying of EB C3G-R
Frequency of occurrence of digestive carrying of EB C3G-R
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03922919
First Posted
February 21, 2019
Last Updated
April 18, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03922919
Brief Title
Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)
Acronym
CEF-IMPACT
Official Title
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
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
April 3, 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
stepped-wedge design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cefotaxime or ceftriaxone group
Arm Type
Active Comparator
Arm Description
free use of cefotaxime or ceftriaxone by the investigator
Arm Title
Cefotaxim group
Arm Type
Experimental
Arm Description
Systematic use of cefotaxime
Intervention Type
Drug
Intervention Name(s)
Cefotaxime Injection
Intervention Description
Systematic use of cefotaxime.
Intervention Type
Procedure
Intervention Name(s)
Rectal swab
Intervention Description
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
Intervention Type
Drug
Intervention Name(s)
Cefotaxime/ceftriaxone
Intervention Description
ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician
Primary Outcome Measure Information:
Title
Frequency of occurrence of digestive carrying of EB C3G-R
Description
Frequency of occurrence of digestive carrying of EB C3G-R
Time Frame
30 days after inclusion
Secondary Outcome Measure Information:
Title
incidence rate of EB C3G-R infections
Description
Evaluate the effect of systematic use of cefotaxime rather than ceftriaxone on the incidence rate of EB C3G-R infections in participating departments.
Time Frame
2 years
Title
number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
Description
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.
Time Frame
30 days after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOUILLER Kevin, Dr
Phone
0381219187
Email
kbouiller@chu-besancon.fr
12. IPD Sharing Statement
Learn more about this trial
Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)
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