Bioavailability of oral ciprofloxacin tablets versus suspension in pediatric cancer patients
Suspended
- Conditions
- CancerAntimicrobial prophylaxisBioequivalenceCiprofloxacin
- Registration Number
- NL-OMON24417
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Age ≥1 years and < 19 years;
-Patients treated with chemotherapy for pediatric cancer
Exclusion Criteria
-Patients unable/unwilling to take one of the ciprofloxacin formulations
-Patients with cystic fibrosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The parameters to determine the bioequivalence are Area Under the Curve (AUC), maximum concentration (Cmax), time of maximum concentration (Tmax) and bioavailability (F). 6 blood samples (>= 0,5 ml each) for the different formulations will be drawn from the available central line; one trough level and five additional samples after administration of ciprofloxacin. These will used to calculate the pharmacokinetic parameters utilizing NONMEM (non-linear mixed effects modeling). These parameters of the formulations of ciprofloxacin will be compared to each other within the same patient. All samples and therefore pk parameters will be determined during steady state.
- Secondary Outcome Measures
Name Time Method