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Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD

2026年6月18日更新者：Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

研究概览

地位

尚未招聘

条件

慢性阻塞性肺疾病 (COPD)

干预/治疗

研究类型

介入性

注册 (估计的)

630

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Hua Zhou, Doctor
电话号码：+86 571 8723 6876
邮箱：zhouhua1@zju.edu.cn

学习地点

中国
- Guangdong
  - Guangzhou、Guangdong、中国
    - The First Affiliated Hospital of Guangzhou Medical University
    - 接触：
      
      Zhengtu Li
- Hubei
  - Wuhan、Hubei、中国
    - Tongji Hospital
    - 接触：
      
      Yuanzhou He
- Jiangxi
  - Nanchang、Jiangxi、中国
    - Second Affiliated Hospital of Nanchang University
    - 接触：
      
      Xinyi Zhang
- Shanghai Municipality
  - Shanghai、Shanghai Municipality、中国
    - Shanghai Pulmonary Hospital, Shanghai, China
    - 接触：
      
      Shuyi Gu
  - Shanghai、Shanghai Municipality、中国
    - Shanghai Tongji Hospital, Tongji University School of Medicine
    - 接触：
      
      Yingzhou Xie
- Sichuan
  - Chengdu、Sichuan、中国
    - West China Hospital
    - 接触：
      
      Chengdi Wang
- Zhejiang
  - Hangzhou、Zhejiang、中国
    - Sir Run Run Shaw Hospital
    - 接触：
      
      Hequan Li
  - Hangzhou、Zhejiang、中国
    - Zhejiang Hospital
    - 接触：
      
      Jian Ye
  - Hangzhou、Zhejiang、中国
    - First affiliated Hospital of Zhejiang University
    - 接触：
      
      Yinan Yao
      
      邮箱：yaoyinan@zju.edu.cn
  - Hangzhou、Zhejiang、中国
    - Red Cross Hospital, Hangzhou, China
    - 接触：
      
      Chuhui Ru
  - Huzhou、Zhejiang、中国
    - Huzhou Central Hospital
    - 接触：
      
      Bin Wang
  - Jiaxing、Zhejiang、中国
    - Affiliated Hospital of Jiaxing University
    - 接触：
      
      Wenyu Chen
  - Jiaxing、Zhejiang、中国
    - Zhejiang Rongjun Hospital
    - 接触：
      
      Lixin Wu
  - Lishui、Zhejiang、中国
    - Lishui hospital of Zhejiang University
    - 接触：
      
      Youyi Du
  - Lishui、Zhejiang、中国
    - The Sixth Affiliated Hospital of Wenzhou Medical University
    - 接触：
      
      Jinwei Huang
  - Quzhou、Zhejiang、中国
    - Zhejiang Quhua Hospital
    - 接触：
      
      Kai Fang
  - Shaoxing、Zhejiang、中国
    - Shaoxing people's Hospital
    - 接触：
      
      Xing Chen
  - Taizhou、Zhejiang、中国
    - Taizhou Hospital
    - 接触：
      
      Junfei Zhu
  - Taizhou、Zhejiang、中国
    - Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University
    - 接触：
      
      Xiaomai Wu
  - Wenzhou、Zhejiang、中国
    - First Affiliated Hospital of Wenzhou Medical University
    - 接触：
      
      Yuping Li

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

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；

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：TMP-SMX Tablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks	药品：Trimethoprim-Sulfamethoxazole (TMP-SMX) Receipt of tablet with the equivalent of one double-strength (DS) TMP-SMX（TMP 160mg + SMZ 800mg） per day by mouth for 4 weeks 其他名称：细菌素磺胺嘧啶
安慰剂比较：placebo Tablet with placebo by mouth every day for 4 weeks	药品：Placebo Receipt of tablet with placebo by mouth every day for 4 weeks

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year 大体时间：Baseline (Day 1) to 12 months	Baseline (Day 1) to 12 months

次要结果测量

结果测量	措施说明	大体时间
The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract 大体时间：1month		1month
The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract 大体时间：3 months，12 months		3 months，12 months
Change from baseline in COPD Assessment Test (CAT) total score 大体时间：1month，3 months，6 months and 12 months	The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome.Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.	1month，3 months，6 months and 12 months
Change from baseline in modified Medical Research Council dyspnea scale (mMRC) 大体时间：1month，3 months，6 months and 12 months	The mMRC scale consists of 5 grades (0-4), based on how much breathlessness limits physical activity. Higher mMRC scores mean a worse outcome.	1month，3 months，6 months and 12 months
All-cause mortality rate 大体时间：Baseline to 12 months		Baseline to 12 months
Airway microbiota analysis 大体时间：Baseline to 1month and 12 months	The microbiome of qualified sputum will be measurable by metagenomic next-generation sequencing (mNGS) technologies. Its characteristic parameters include the alpha diversity and beta diversity of the microbiome.	Baseline to 1month and 12 months
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) 大体时间：Baseline to 3 months，6 months and 12 months		Baseline to 3 months，6 months and 12 months
Incidence rate of adverse events 大体时间：2 weeks and 1 month		2 weeks and 1 month