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Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

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ClinicalTrials.gov Identifier: NCT00190151
Recruitment Status : Terminated (terminated)
First Posted : September 19, 2005
Last Update Posted : September 18, 2012
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ciprofloxacin Not Applicable

Detailed Description:
Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
Study Start Date : September 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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Primary Outcome Measures :
  1. Occurrence of bacterial resistance in commensal flora

Secondary Outcome Measures :
  1. Pharmacokinetic/pharmacodynamic relationship


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:


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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): NCT00190151


Locations
France
Hôpital Bichat Claude Bernard, 46 rue Henri Huchard
Paris, France, 75877
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Bruno Fantin Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France
Principal Investigator: Xavier Duval Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zakia IDIR, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00190151     History of Changes
Other Study ID Numbers: P031007
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ciprofloxacin
commensal flora
resistance
Pharmacokinetic

Additional relevant MeSH terms:
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors