Bioavailability of oral ciprofloxacin tablets and suspension in pediatric cancer patients

Erasmus MC0 个研究点开始时间: 2013年8月8日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•-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

•-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

发起方