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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03922919

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted April 22, 2019

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

  • Condition or Disease:Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
  • Intervention/Treatment: Drug: Cefotaxime Injection
    Procedure: Rectal swab
    Drug: Cefotaxime/ceftriaxone
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2018
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

France
CHU de Besançon
Besançon

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

More Information
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Infection Communicable Diseases