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