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

NCT07665359 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0378
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 20

Brief 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)

Keywords

Chronic Obstructive Pulmonary Disease; Pneumocystis jirovecii; Trimethoprim-Sulfamethoxazole

Outcome Measures

Primary Outcomes (1)

• Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year

  Baseline (Day 1) to 12 months

Secondary Outcomes (8)

• The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract

  1month

• The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract

  3 months，12 months

• Change from baseline in COPD Assessment Test (CAT) total score

  1month，3 months，6 months and 12 months

• Change from baseline in modified Medical Research Council dyspnea scale (mMRC)

  1month，3 months，6 months and 12 months

• All-cause mortality rate

  Baseline to 12 months

Study Arms (2)

TMP-SMX

EXPERIMENTAL

Tablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks

Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)

placebo

PLACEBO COMPARATOR

Tablet with placebo by mouth every day for 4 weeks

Drug: Placebo

Interventions

Trimethoprim-Sulfamethoxazole (TMP-SMX) DRUG

Receipt of tablet with the equivalent of one double-strength (DS) TMP-SMX（TMP 160mg + SMZ 800mg） per day by mouth for 4 weeks

Also known as: Bactrim, Sulfatrim

TMP-SMX

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 and above，male or female；
• PCR detection of Pneumocystis jirovecii in induced sputum is positive；
• Informed consent

You may not qualify if:

• 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；

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• Zhejiang Rongjun Hospital: collaborator
• Zhejiang Quhua Hospital: collaborator
• West China Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Huzhou Central Hospital: collaborator
• Shaoxing People's Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Red Cross Hospital, Hangzhou, China: collaborator
• Taizhou Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Zhejiang Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Lishui hospital of Zhejiang University: collaborator
• Tongji Hospital: collaborator
• The Sixth Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (20)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, China

Location

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Red Cross Hospital, Hangzhou, China

Hangzhou, Zhejiang, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Location

Zhejiang Rongjun Hospital

Jiaxing, Zhejiang, China

Location

Lishui hospital of Zhejiang University

Lishui, Zhejiang, China

Location

The Sixth Affiliated Hospital of Wenzhou Medical University

Lishui, Zhejiang, China

Location

Zhejiang Quhua Hospital

Quzhou, Zhejiang, China

Location

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Location

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, Zhejiang, China

Location

Taizhou Hospital

Taizhou, Zhejiang, China

Location

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Hua Zhou, Doctor

CONTACT

+86 571 8723 6876; zhouhua1@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)