Treating Pneumocystis jirovecii in the airways of adults with COPD to reduce flare-ups
Tests trimethoprim-sulfamethoxazole against placebo in adults with COPD carrying Pneumocystis jirovecii.
Plain-language title generated from the registry record
Registry title: Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD
Key facts
- Where
- Chengdu, Guangzhou, Hangzhou, Huzhou, Jiaxing, Lishui, Nanchang, Quzhou, Shanghai, Shaoxing, Taizhou, Wenzhou, and Wuhan, ChinaSee the 20 sites
Where in China
- West China HospitalChengdu, ChinaNo longer taking part
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- First Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaNo longer taking part
- Red Cross Hospital, Hangzhou, ChinaHangzhou, ChinaNo longer taking part
- Sir Run Run Shaw HospitalHangzhou, ChinaNo longer taking part
- Zhejiang HospitalHangzhou, ChinaNo longer taking part
- Huzhou Central HospitalHuzhou, ChinaNo longer taking part
- Affiliated Hospital of Jiaxing UniversityJiaxing, ChinaNo longer taking part
- Zhejiang Rongjun HospitalJiaxing, ChinaNo longer taking part
- Lishui hospital of Zhejiang UniversityLishui, ChinaNo longer taking part
- The Sixth Affiliated Hospital of Wenzhou Medical UniversityLishui, ChinaNo longer taking part
- Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaNo longer taking part
- Zhejiang Quhua HospitalQuzhou, ChinaNo longer taking part
- Shanghai Pulmonary Hospital, Shanghai. ChinaShanghai, ChinaNo longer taking part
- Shanghai Tongji Hospital, Tongji University School of MedicineShanghai, ChinaNo longer taking part
- Shaoxing People's HospitalShaoxing, ChinaNo longer taking part
- Taizhou HospitalTaizhou, ChinaNo longer taking part
- Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical UniversityTaizhou, ChinaNo longer taking part
- First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNo longer taking part
- Tongji HospitalWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07665359
- Record updated
- 24 June 2026
- Original description
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.Read full original descriptionShow less
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
Inclusion: 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: 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)；; Currently using coumarin, phenytoin, pioglitazone, repaglinide, rosiglitazone, glipizide or glibenclamide; 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.)；; 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 participating in other interventional clinical studies；.