Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-FC

IVERSITY OF LIVERPOO0 个研究点目标入组 286 人开始时间: 2022年1月18日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•1. Diagnosis of cystic fibrosis
•2. Children over the age of 28 days, older children and adult CF participants are all eligible with no upper age limitation.
•3. Competent adults should provide fully informed written consent to participate in the trial
•4. Minors should have proxy consent by the parent or legal guardian and should provide assent where applicable to participate in the trial
•5. The participant should have isolated P. aeruginosa and should be either:
•a. P. aeruginosa -naïve (i.e. has never previously isolated P. aeruginosa) or
•b. P. aeruginosa -free (i.e. any cough or sputum samples within the previous year (365 days) should be P. aeruginosa free)
•6. The participant should be able to commence treatment no later than 21 days from the date of a P. aeruginosa positive microbiology report.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•1. Antibiotic resistance of the current P. aeruginosa sample to any of: ciprofloxacin, ceftazidime, tobramycin or colistin reported by local microbiology laboratory lab
•2. Known participant hypersensitivity to either ciprofloxacin, ceftazidime, tobramycin or colistin
•3. Other known contraindications to any of ciprofloxacin, ceftazidime, tobramycin or colistin, including previous aminoglycoside hearing or renal damage
•4. Participant receiving P. aeruginosa suppressing treatment, in particular nebulised colistin or tobramycin, or oral ciprofloxacin for the previous nine calendar months. Please note, short courses of oral ciprofloxacin or intravenous antibiotics (with an anti-pseudomonal spectrum of action) are not an exclusion unless they are given to treat proven infections with P. aeruginosa
•5. Treatment with other anti-pseudomonal nebuliser
•6. Pregnant and nursing mothers (women of child bearing age will be counselled on the risks of becoming pregnant during the trial and will be offered a pregnancy test)
•7. Previous randomisation in TORPEDO-CF study
•8. Previous participation in another related intervention trial within four weeks of taking part in TORPEDO-CF

发起方

IVERSITY OF LIVERPOO