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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year [Срок оценки: Baseline (Day 1) to 12 months]

Вторичные конечные точки (8)

• The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract [Срок оценки: 1month]
• The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract [Срок оценки: 3 months，12 months]
• Change from baseline in COPD Assessment Test (CAT) total score [Срок оценки: 1month，3 months，6 months and 12 months]
• Change from baseline in modified Medical Research Council dyspnea scale (mMRC) [Срок оценки: 1month，3 months，6 months and 12 months]
• All-cause mortality rate [Срок оценки: Baseline to 12 months]
• Airway microbiota analysis [Срок оценки: Baseline to 1month and 12 months]
• Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: Baseline to 3 months，6 months and 12 months]
• Incidence rate of adverse events [Срок оценки: 2 weeks and 1 month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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；

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Tongji Hospital — Ухань
• Second Affiliated Hospital of Nanchang University — Nanchang
• Shanghai Pulmonary Hospital, Shanghai, China — Шанхай
• Shanghai Tongji Hospital, Tongji University School of Medicine — Шанхай
• West China Hospital — Чэнду
• First Affiliated Hospital of Zhejiang University — Ханчжоу
• Red Cross Hospital, Hangzhou, China — Ханчжоу
• … и ещё 12 центров

Идентификаторы

NCT: NCT07665359 · 2026-0378

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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