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

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Zhejiang Rongjun Hospital

  collaborator OTHER_GOV

• Zhejiang Quhua Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Red Cross Hospital, Hangzhou, China

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Zhejiang Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The Sixth Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-05-01

Completion

2029-05-01

Countries

• China

Study Locations