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NCT07665359
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Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2026-07-01

Completion Date

2029-05-01

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

Placebo

Receipt of tablet with placebo by mouth every day for 4 weeks

Locations (20)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Tongji Hospital

Wuhan, Hubei, China

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, China

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital

Chengdu, Sichuan, China

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Red Cross Hospital, Hangzhou, China

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Zhejiang Rongjun Hospital

Jiaxing, Zhejiang, China

Lishui hospital of Zhejiang University

Lishui, Zhejiang, China

The Sixth Affiliated Hospital of Wenzhou Medical University

Lishui, Zhejiang, China

Zhejiang Quhua Hospital

Quzhou, Zhejiang, China

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, Zhejiang, China

Taizhou Hospital

Taizhou, Zhejiang, China

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China