Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

CEREMI is an open, randomised prospective study in parallel groups in healthy volunteers. This study compare the effect of a monotherapy by ceftriaxone or cefotaxime on the emergence of resistance of enterobacteria to 3rd-generation cephalosporins within the intestinal microbiota. Each volunteer will be treated for 3 days by either ceftriaxone (1 gram per day) or cefotaxime (1 gram every 8 hours).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cefotaxime; Cefoxitin; Ceftriaxone; Cephalosporins

Criteria

Inclusion Criteria:

• Age between 18 and 65 years

• Volunteer regarded as healthy after detailed examination

• Subject whose entourage (person living under the same roof) does not present any chronic disease throughout the course and did not receive antibiotics within 15 days.

• Effective contraception for women in reproductive age and negative pregnancy test before inclusion

• Normal intestinal passage (one stool per day)

• Negative urinalysis for toxic substances

• Normal blood test (including blood and platelets counts, prothrombin, ionograms, Liver function tests)

• Negative HIV and HCV (hepatitis C virus) test, no HBV (hepatitis B virus)chronic infection

• Normal weight (BMI comprised between 19 and 29 kg/m²)

• Freely obtained consent

• Health insurance beneficiary

Exclusion Criteria:

• Antibiotic therapy in the previous 6 months

• Hospitalisation in the previous 12 months;

• Active infection

• Ongoing treatment

• Any chronic disease

• Allergy to one of the study drugs

• Any contraindications to β-lactam therapy in particular to penicillins or cephalosporins

• Pregnancy or no effective contraception, suckling women

• Subject, as determined by the investigating physician, could not observing during the study, or unable to communicate because of language or mental disorders barrier;

• Subject participating simultaneously in another biomedical research

• Subject can not be contacted in case of emergency;

• Subject about legally protected under tutorship or curators;

• Subject deprived of freedom under judicial or administrative constraints

Secondary exclusion criteria

• No pre-treatment stool sample obtained

• More than one stool sample missing from D1 to D7