Cancer Antimicrobial prophylaxis Bioequivalence Ciprofloxacin
Conditions
Interventions
Patients are treated with ciprofloxacin as standard treatment. However for this study, ciprofloxacin will be relabeled as study medication for the duration of the study. The total treatment study peri
subjects will start with 7 days of oral solution and thereafter switched to 7 days of tablets or vice versa. Patients will be randomized to determine the starting formulation. During the treatment wit
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Age ≥1 years and < 19 years; - Patients treated with chemotherapy for pediatric cancer - Patients who will receive ciprofloxacin treatment as antimicrobial prophylaxis according to standard supportive care guidelines - Creatinine within normal limits according to age - Possible to withhold antacids, sucralfate, iron, or other di/trivalent cations (e.g. zinc) for 6 h prior and 2 h after administration of ciprofloxacin on days of sampling (only one administration per day) - Possible to withhold enteral feeding 4 h prior and 2 h after administration of ciprofloxacin on days of sampling (only one administration per day).
Exclusion criteria
Exclusion criteria: - Patients unable/unwilling to take one of the ciprofloxacin formulations - Patients with cystic fibrosis - Patients with celiac disease - Patients with abnormalities in the gastrointestinal tract, including severe chemotherapy induced mucositis/diarrhea - Known or suspected malabsorption state - Previous allergic reactions to fluorchinolones - Hepatic insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactS.D.T. Sassen
Erasmus MC Dr Molewaterplein 60
Outcome results
None listed