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Clinical Trials/NCT00190151
NCT00190151
Terminated
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country48 target enrollmentSeptember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
48
Locations
1
Primary Endpoint
Occurrence of bacterial resistance in commensal flora
Status
Terminated
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
July 2005
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • healthy volunteers

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Occurrence of bacterial resistance in commensal flora

Secondary Outcomes

  • Pharmacokinetic/pharmacodynamic relationship

Study Sites (1)

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