NCT07665359Not yet recruiting
Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 630 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 May 2029
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- COPD
- NCT number
- NCT07665359
What you commit to
- Study type: Interventional
- Planned participants: 630
- From 1 Jul 2026 to the primary completion date, 1 May 2029
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.)；
Lab values
- Severe liver and kidney dysfunction (ALT/AST \> 3 times the upper limit of normal value, eGFR \< 60 mL/min/1.73m²)；
Other
- Pregnant, lactating women or those planning to become pregnant;
- Folic acid deficiency-induced microcytic anemia;
- Currently participating in other interventional clinical studies；
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Red Cross Hospital, Hangzhou, China Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Zhejiang Rongjun Hospital Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Affiliated Hospital of Jiaxing University Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| The Sixth Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| Lishui hospital of Zhejiang University Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Zhejiang Quhua Hospital Coordinator of this site? Confirm its status | Quzhou | China | Unknown status |
| Shanghai Pulmonary Hospital, Shanghai. China Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Tongji Hospital, Tongji University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shaoxing People's Hospital Coordinator of this site? Confirm its status | Shaoxing | China | Unknown status |
| Taizhou Hospital Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.