Bioavailability of oral ciprofloxacin tablets versus suspension in pediatric cancer patients

Completed

• Conditions: bacterial infections; Cancer (not specified); 10004018; 10027656

• Registration Number: NL-OMON38595
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The parameters to determine the bioequivalence are Area Under the Curve (AUC),<br /><br>maximum concentration (Cmax) and time of maximum concentration (Tmax). These<br /><br>parameters of both formulations of ciprofloxacin will be compared to each other<br /><br>within the same patient. All samples and therefore pk parameters will be<br /><br>determined during steady state. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>