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

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ClinicalTrials.gov Identifier: NCT03922919
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Infectious Disease - Resistant Enterobacteriaceae (Diagnosis) Drug: Cefotaxime Injection Procedure: Rectal swab Drug: Cefotaxime/ceftriaxone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: stepped-wedge design
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 3, 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cefotaxime or ceftriaxone group
free use of cefotaxime or ceftriaxone by the investigator
Procedure: Rectal swab
Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion

Drug: Cefotaxime/ceftriaxone
ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician

Experimental: Cefotaxim group
Systematic use of cefotaxime
Drug: Cefotaxime Injection
Systematic use of cefotaxime.

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




Primary Outcome Measures :
  1. Frequency of occurrence of digestive carrying of EB C3G-R [ Time Frame: 30 days after inclusion ]
    Frequency of occurrence of digestive carrying of EB C3G-R


Secondary Outcome Measures :
  1. incidence rate of EB C3G-R infections [ Time Frame: 2 years ]
    Evaluate the effect of systematic use of cefotaxime rather than ceftriaxone on the incidence rate of EB C3G-R infections in participating departments.

  2. number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R) [ Time Frame: 30 days after inclusion ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922919


Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: BOUILLER Kevin, Dr    0381219187    kbouiller@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03922919     History of Changes
Other Study ID Numbers: API/2016/74
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Ceftriaxone
Cephalosporins
Cefotaxime
Cefoxitin
Anti-Bacterial Agents
Anti-Infective Agents