NCT07665359尚未招募不适用

A Multicenter, Prospective, Double-blind, Randomized Controlled Study on the Impact of Decolonization Treatment on the Frequency of Acute Exacerbation in Patients With Chronic Obstructive Pulmonary Disease Colonized With Pneumocystis Jirovecii

Second Affiliated Hospital, School of Medicine, Zhejiang University20 个研究点分布在 1 个国家目标入组 630 人开始时间: 2026年7月1日最近更新: 2026年6月24日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 630
试验地点: 20

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Previous researches have found the common colonization of Pneumocystis jirovecii (Pj) in the airways of people with chronic obstructive pulmonary disease (COPD). And this colonization may exacerbate airway inflammation and increase the frequency of acute exacerbation in people with COPD.

The goal of this clinical trial is to study if "decolonization treatment" (that is, removing these colonizing Pj) works to improve the prognosis of COPD colonized by Pj in adults. The main question it aims to answer is:

Does the Trimethoprim-Sulfamethoxazole (TMP-SMX, an antibiotics) decolonization treatment reduce the frequency of acute exacerbation in participants with COPD colonized by Pj who have a high risk of acute exacerbation.

Researchers will compare TMP-SMX to a placebo (a look-alike substance that contains no drug) to see if TMP-SMX works to reduce the frequency of acute exacerbation of COPD.

Participants will:

Take drug TMP-SMX or a placebo 2 tablet every day for 4 weeks.
Visit the clinic after 2 weeks, 1 month, 3 months, 6 months and 12 months for survey questions, checkups and tests.
Keep a diary of their symptoms and the number of times they experience acute exacerbations

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 40 and above，male or female；
•COPD who meet the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2026 ( post-bronchodilator FEV1/forced vital capacity [FVC] ratio < 0.7 and post-bronchodilator FEV1% predicted ≥ 30%), and have documented history of high exacerbation risk (Group E, defined as exacerbation history of ≥ 1 moderate or severe acute exacerbation within 12 months prior to inclusion)；
•Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to inclusion; Double therapy (LABA + LAMA) allowed if ICS is contraindicated；
•PCR detection of Pneumocystis jirovecii in induced sputum is positive；
•Informed consent

排除标准

•Allergic to TMP, SMX or sulfonamide drugs；
•There are pneumonia or other infections that require long-term use of antibacterial drugs (such as tuberculosis, NTM, other fungi, etc.)；
•Having used antibiotics within the previous 4 weeks prior to screening；
•Experience of AECOPD events within the previous 4 weeks prior to screening;
•Having a definite immunodeficiency disorder or receiving immunosuppressive therapy (such as HIV, agranulocytosis, solid organ or hematopoietic stem cell transplantation, malignant tumors, using long-term high-dose hormones > 20mg/day prednisone equivalent for more than 4 weeks)；
•Severe liver and kidney dysfunction (ALT/AST > 3 times the upper limit of normal value, eGFR < 60 mL/min/1.73m²)；
•Pregnant, lactating women or those planning to become pregnant;
•Folic acid deficiency-induced microcytic anemia;
•Currently using coumarin, phenytoin, pioglitazone, repaglinide, rosiglitazone, glipizide or glibenclamide;
•Currently participating in other interventional clinical studies；

研究者

发起方

Second Affiliated Hospital, School of Medicine, Zhejiang University

申办方类型

Other

责任方

Sponsor

研究点 (20)

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