ISRCTN02734162已完成4 期
Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis
niversity Hospitals Bristol (UK)0 个研究点目标入组 286 人开始时间: 2009年5月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 286
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33007285/ results (added 07/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34806975/ (added 23/11/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/04/2011:
- •1. Diagnosis of CF
- •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 particpiate 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 patient should have isolated P.aeruginosa and should be either:
- •5.1. P. aeruginosa-naïve (i.e., has never previously isolated P. aeruginosa) or
- •5.2. P. aeruginosa-free (i.e., a minimum number of four consecutive cough or sputum samples should be P. aeruginosa free within a 12 month period to satisfy eligibility)
- •6. The particpiant should be able to commence treatment no later than 21 days from the date of a P. aeruginosa positive microbiology report
- •Previous inclusion criteria:
- •1. Diagnosis of CF
- •2. The patient should have given full written consent, or assent where applicable, to participate in the trial
- •3. The participant should be able to commence treatment no later than three weeks after the clinical team has been informed that P.aeruginosa has been isolated
- •4. The patient should have isolated P.aeruginosa and should be either:
- •4.1. Pseudomonas-naïve (i.e. has never previously isolated P. aeruginosa) or
- •4.2. Pseudomonas-free i.e. has not isolated P. aeruginosa from cough swab, sputum or bronchoalveolar lavage samples within the previous 12 months
排除标准
- •Current exclusion criteria as of 14/04/2011:
- •1. Antibiotic resistance of the current P.aeruginosa sample to any of: ciprofloxacin, ceftazidime, tobramycin or colistin reported by local microbiology laboratory
- •2. Known patient 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 suppresing treatment, in particular nebulised colistin or tobramycin, or oral ciproflxacin for the previous 9 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 preganancy test)
- •7. Previous randomisation in TORPEDO-CF study
- •8. Previous participation in another intervention trial within four weeks of taking part in TORPEDO-CF
- •Previous exclusion criteria:
- •1. Antibiotic resistance of the current P.aeruginosa sample to any of: ciprofloxacin, ceftazidime, or tobramycin reported by local microbiology lab
- •2. Known patient hypersensitivity to either ciprofloxacin, ceftazidime or tobramycin
- •3. Other known contraindications to any of ciprofloxacin, ceftazidime or tobramycin, including previous aminoglycoside hearing or renal damage
- •4. Pregnant women
研究者
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