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

18 juni 2026 bijgewerkt door: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

630

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Zhengtu Li
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital
        • Contact:
          • Yuanzhou He
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Second Affiliated Hospital of Nanchang University
        • Contact:
          • Xinyi Zhang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Pulmonary Hospital, Shanghai, China
        • Contact:
          • Shuyi Gu
      • Shanghai, Shanghai Municipality, China
        • Shanghai Tongji Hospital, Tongji University School of Medicine
        • Contact:
          • Yingzhou Xie
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital
        • Contact:
          • Chengdi Wang
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital
        • Contact:
          • Hequan Li
      • Hangzhou, Zhejiang, China
        • Zhejiang Hospital
        • Contact:
          • Jian Ye
      • Hangzhou, Zhejiang, China
        • First affiliated Hospital of Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Red Cross Hospital, Hangzhou, China
        • Contact:
          • Chuhui Ru
      • Huzhou, Zhejiang, China
        • Huzhou Central Hospital
        • Contact:
          • Bin Wang
      • Jiaxing, Zhejiang, China
        • Affiliated Hospital of Jiaxing University
        • Contact:
          • Wenyu Chen
      • Jiaxing, Zhejiang, China
        • Zhejiang Rongjun Hospital
        • Contact:
          • Lixin Wu
      • Lishui, Zhejiang, China
        • Lishui hospital of Zhejiang University
        • Contact:
          • Youyi Du
      • Lishui, Zhejiang, China
        • The Sixth Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Jinwei Huang
      • Quzhou, Zhejiang, China
        • Zhejiang Quhua Hospital
        • Contact:
          • Kai Fang
      • Shaoxing, Zhejiang, China
        • Shaoxing people's Hospital
        • Contact:
          • Xing Chen
      • Taizhou, Zhejiang, China
        • Taizhou Hospital
        • Contact:
          • Junfei Zhu
      • Taizhou, Zhejiang, China
        • Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University
        • Contact:
          • Xiaomai Wu
      • Wenzhou, Zhejiang, China
        • First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Yuping Li

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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；

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TMP-SMX
Tablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks
Geneesmiddel: 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
Andere namen:
  • Bactrim
  • Sulfatrim
Placebo-vergelijker: placebo
Tablet with placebo by mouth every day for 4 weeks
Geneesmiddel: Placebo
Receipt of tablet with placebo by mouth every day for 4 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year
Tijdsspanne: Baseline (Day 1) to 12 months
Baseline (Day 1) to 12 months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 mei 2029

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0378

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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