2025-524454-34-00招募中4 期
Randomized, double-blind, parallel-group clinical trial, compared with placebo to evaluate the efficacy and safety of three antibiotic treatment regimens for the eradication of primary P. aeruginosa infection in patients with bronchiectasis
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau13 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 13
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of three different antibiotic regimens, compared to placebo, for the eradication of PA in adults with NCFB and primary PA infection. The primary outcome will focus on microbiological eradication, which will be assessed through negative cultures at 3 months after treatment initiation.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults aged >18 years
- •Diagnosis of NCFB based on clinical symptoms and HRCT imaging within the last five years.
- •Primary PA infection, identified by isolation of PA from a respiratory sample, meeting one of the following criteria: -First isolation: The patient has never had a positive culture for PA from a respiratory sample* before. -PA persistence: The patient had a first isolation of PA from a respiratory sample during an exacerbation, followed by systemic antibiotic treatment (oral or intravenous), with PA persisting in a respiratory sample four weeks after the completion of treatment. -New isolation: The patient had a prior positive culture for PA from a respiratory sample, with at least three negative cultures for PA over the preceding year (spaced at least one month apart) without chronic antipseudomonal treatment during this period. * Respiratory sample: sputum or bronchoscopic sample obtained during routine clinical practice.
- •Clinically stable at the time of inclusion: no exacerbations in the past month and no need for intravenous medications or hospitalization.
- •Signed informed consent
排除标准
- •Infection with PA resistant to the treatments under investigation or infection with other bacteria
- •Patients participating in other clinical trials.
- •Refusal to participate.
- •Patients with contraindications to the study medications (ciprofloxacin or colistin).
- •Patients with a history of intolerance to inhaled treatment via nebulization.
- •Patients with cystic fibrosis, uncontrolled asthma, tuberculosis, or immunosuppression.
- •Patients with uncontrolled systemic diseases within the last 3 months.
- •Patients receiving chronic antibiotic therapy.
- •Patients with a glomerular filtration rate < 30 ml/min/1.73 m².
- •Women of childbearing age not using a highly effective contraceptive method.
- •Pregnant or breastfeeding women.
研究者
Rosa M. Antonijoan Arbos
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (13)
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