Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: ciprofloxacin (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Bruno Fantin, Study Chair, Affiliation: Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France
Xavier Duval, Principal Investigator, Affiliation: Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France
Summary
Bacterial resistance to antibiotics has been a growing therapeutic problem since the late
1980s. Resistant strains of pathogenic bacteria can arise through initial selection of
resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the
commensal flora will be assessed in 48 healthy volunteers receiving variable doses of
ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic
characteristics of ciprofloxacin.
Clinical Details
Official title: Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
Study design: Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Occurrence of bacterial resistance in commensal flora
Secondary outcome: Pharmacokinetic/parmacodynamic relationship
Detailed description:
Bacterial resistance to antibiotics has been a growing therapeutic problem since the late
1980s. Resistant strains of pathogenic bacteria can arise through initial selection of
resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the
commensal flora will be assessed in 48 healthy volunteers receiving variable doses of
ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic
characteristics of ciprofloxacin.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
-
Locations and Contacts
Hôpital Bichat Claude Bernard, 46 rue Henri Huchard, Paris 75877, France
Additional Information
Starting date: September 2004
Ending date: July 2005
Last updated: November 18, 2005
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