COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659033
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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).

Condition or disease Intervention/treatment Phase
Emergence of Bacterial Resistance to Antibiotics Drug: ceftriaxone Drug: Cefotaxime Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.
Study Start Date : March 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ceftriaxone
healthy volunteer who receive ceftriaxone
Drug: ceftriaxone
ceftriaxone (1 gram per day)
Other Name: cephalosporin 3rd generation

Active Comparator: cefotaxime
healthy volunteer who receive cefotaxime
Drug: Cefotaxime
cefotaxime (1 gram every 8 hours)
Other Name: cephalosporin 3rd generation




Primary Outcome Measures :
  1. The area under the curve of the 3rd generation cephalosporins resistant enterobacteria in the intestinal microbiota between D0 and D7. [ Time Frame: within the first 7 days ]

Secondary Outcome Measures :
  1. The area under the curve of enterobacteriaceae resistant to C3G accounts (regardless of the resistance mechanism) from D0 to D15 in each treatment group. [ Time Frame: within the first 15 days ]
  2. Proportion of patients with 3rd generation cephalosporins resistant enterobacteria in the intestinal microbiota (regardless of the resistance mechanism) at D30 at D90 and at D180 in each treatment group. [ Time Frame: D30, D90 and D180 ]
  3. Area under the curve of enterobacteriaceae resistant to C3G accounts distinguishing the resistance mechanism (B lactamase,plasmid cephalosporinase or cephalosporinase) from D0 to D15 in each treatment group. [ Time Frame: within the first 15 days ]
  4. Proportion of patients with 3rd generation cephalosporins resistant enterobacteria in the intestinal microbiota (distinguishing the resistance mechanism) at D30 at D90 and at D180 in each treatment group. [ Time Frame: D30, D90 and D180 ]
  5. Area under the curve of total coliform accounts from D0 to D 7 and D0 to D15 in each treatment group. [ Time Frame: within the first 15 days ]
  6. Change in total coliform accounts between D0 and D30 between D0 and D90 and between D0 and D180 in each treatment group. [ Time Frame: D30, D90 and D180 ]
  7. The area under the curve of aeruginosa accounts, S. aureus, Enterococcus spp., Clostridium difficile and yeasts from D0 to D7 and D0 to D15 in each treatment group. [ Time Frame: within the first 15 days ]
  8. The area under the curve of β-lactamase activity of the intestinal microbiota from D0 to D7 and D0 to D15 in each treatment group. [ Time Frame: within the first 15 days ]
  9. Proportion of patients with β-lactamase activity in the stools at D30, D90 and D180 in each treatment group. [ Time Frame: D30, D90 and D 180 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02659033


Locations
Layout table for location information
France
Hôpital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Xavier Duval, Profesor Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02659033    
Other Study ID Numbers: CRC13-179 / P140904
2014-005485-30 ( EudraCT Number )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
microbiota
resistant bacteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Ceftriaxone
Cephalosporins
Cefotaxime
Cefoxitin
Anti-Bacterial Agents
Anti-Infective Agents