Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190151

Purpose

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	Intervention
Healthy Volunteers	Drug: ciprofloxacin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

Resource links provided by NLM:

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Occurrence of bacterial resistance in commensal flora

Secondary Outcome Measures:

Pharmacokinetic/parmacodynamic relationship

Estimated Enrollment:	48
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fantin B, Duval X, Massias L, Alavoine L, Chau F, Retout S, Andremont A, Mentré F. Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. J Infect Dis. 2009 Aug 1;200(3):390-8.

ClinicalTrials.gov Identifier:	NCT00190151 History of Changes
Other Study ID Numbers:	0324 P03 1007, grantP03 1007
Study First Received:	September 12, 2005
Last Updated:	November 18, 2005
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

ciprofloxacin
commensal flora
resistance
Parmacokinetic

Additional relevant MeSH terms:

Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012