Randomised controlled trial to assess the benefits of early use ciprofloxacin versus placebo in children with cystic fibrosis to minimise the risks of chronic infection with pseudomonas aeruginosa

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 45 人开始时间: 2010年5月12日最近更新: 2017年10月30日

适应症

试验速览

暂无简介。

•1. Confirmed diagnosis of cystic fibrosis and attending the regional CF service for care exclusively at Southampton or at Southampton and Winchester or Poole General Hospitals
•2. Aged 2 - 14 years, either sex
•3. Negative ELISA serology for P. aeruginosa at study entry
•4. Not chronically infected with pseudomonas aeruginosa

•1. Positive pseudomonas serology on ELISA testing
•2. Any other evidence suggesting chronic P. aeruginosa infection
•3. Chronic infection with any other gram negative CF pathogen
•4. Past history of allergic reaction or any other significant adverse reaction to previous treatment with oral ciprofloxacin
•5. Ongoing participation any other clinical trial at time of study entry
•6. Parents or guardians unwilling to give informed consent for study inclusion
•7. Patients who have a recognised indication for other antibiotics
•8. Immunosuppressive/immunomodulatory therapy
•9. Significant immunocompromise (e.g., human immunodeficiency virus [HIV] infection)
•10. Advanced malignancy
•12. Children not likely to survive the time period of the intervention
•13. Patients who have undergone organ transplantation (including bone marrow transplantation)
•14. Patients undergoing plasma exchange or whole blood exchange transfusion
•15. Treatment with an investigational drug or device within the last 30 days prior to enrolment
•16. Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.

发起方

Southampton University Hospitals NHS Trust (UK)