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NCT Number: NCT07665359

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

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

Other names: Bactrim, Sulfatrim

Placebo

Drug

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

Primary outcomes

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

    Time frame: Baseline (Day 1) to 12 months

Secondary outcomes

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

    Time frame: 1month

  2. The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract

    Time frame: 3 months,12 months

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

    Time frame: 1month,3 months,6 months and 12 months

    The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome.Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.

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

    Time frame: 1month,3 months,6 months and 12 months

    The mMRC scale consists of 5 grades (0-4), based on how much breathlessness limits physical activity. Higher mMRC scores mean a worse outcome.

  5. All-cause mortality rate

    Time frame: Baseline to 12 months

  6. Airway microbiota analysis

    Time frame: Baseline to 1month and 12 months

    The microbiome of qualified sputum will be measurable by metagenomic next-generation sequencing (mNGS) technologies. Its characteristic parameters include the alpha diversity and beta diversity of the microbiome.

  7. Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline to 3 months,6 months and 12 months

  8. Incidence rate of adverse events

    Time frame: 2 weeks and 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhou, Doctor

CONTACT

[email protected]

+86 571 8723 6876

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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