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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 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

630

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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；

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: TMP-SMX
Tablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks
Läkemedel: 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
Andra namn:
  • Bactrim
  • Sulfatrim
Placebo-jämförare: placebo
Tablet with placebo by mouth every day for 4 weeks
Läkemedel: Placebo
Receipt of tablet with placebo by mouth every day for 4 weeks

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract
Tidsram: 1month
1month
The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract
Tidsram: 3 months，12 months
3 months，12 months
Change from baseline in COPD Assessment Test (CAT) total score
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline to 12 months
Baseline to 12 months
Airway microbiota analysis
Tidsram: 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)
Tidsram: Baseline to 3 months，6 months and 12 months
Baseline to 3 months，6 months and 12 months
Incidence rate of adverse events
Tidsram: 2 weeks and 1 month
2 weeks and 1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 maj 2029

Avslutad studie (Beräknad)

1 maj 2029

Studieregistreringsdatum

Först inskickad

15 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-0378

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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