The availability of ciprofloxacin in the body after administration of tablets and suspension in pediactric cancer patients

Phase 1

• Conditions: Microbial prophylaxis during cancer treatment; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002744-89-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified