Infectious Disease - Resistant Enterobacteriaceae (Diagnosis) Clinical Trial
— CEF-IMPACTOfficial title:
Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)
| Verified date | February 2019 |
| Source | Centre Hospitalier Universitaire de Besancon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Recruiting |
| Enrollment | 250 |
| Est. completion date | October 2020 |
| Est. primary completion date | April 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Besançon | Besançon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Besancon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 2 years | |
| Secondary | 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. | 30 days after inclusion |