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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02031588 |
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Date of registration:
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07/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.
EVOTAR |
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Scientific title:
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Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients. |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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77 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02031588 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Victoire De Latours, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion criteria for the patients treated with antibiotics
- Adult patient hospitalized in a participating ward of the hospital for an expected
duration of more than 24 hours.
- Treatment by ceftriaxone and / or a fluoroquinolone started by the attending
physicians during hospitalization.
- No hospitalization or stay in nursing home in the previous three months.
- No use of antibiotics in the last 3 months
- Not receiving other antibiotics than ceftriaxone or FQ
- Informed consent
Inclusion criteria for the patients in the reference group
- Adult patient hospitalized in a participating ward of the hospital for an expected
duration of more than 24 hours.
- Not receiving any antibiotic and not expected to receive any during hospitalization
- No hospitalization or stay in nursing home in the previous three months.
- No use of antibiotics in the last 3 months
- Informed consent
Exclusion criteria
- Pregnant or nursing women
- Patient who underwent colectomy or suffering from chronic intestinal disease
(inflammatory intestinal disease or short bowel syndrome)
- Patient who used a bowel preparation solution for colonoscopy during hospitalization
or in the previous week.
- Protected adult patient (deputyship or guardianship)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bacterial Infections
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Primary Outcome(s)
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Describe the changes in the composition of the gut microbial flora in relation to the initial flora (T0) in patients receiving antibiotics, by date of sampling, treatment received, dose, duration of therapy, ward, and duration of hospital stay.
[Time Frame: 1 year]
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Secondary Outcome(s)
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A secondary endpoint is to describe the changes in the gut microbiota of hospitalized patients not receiving antibiotics.
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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