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

18 de junio de 2026 actualizado por: 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

630

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Hua Zhou, Doctor
  • Número de teléfono: +86 571 8723 6876
  • Correo electrónico: zhouhua1@zju.edu.cn

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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；

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: TMP-SMX
Tablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks
Droga: 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
Otros nombres:
  • Bactrim
  • Sulfatrim
Comparador de placebos: placebo
Tablet with placebo by mouth every day for 4 weeks
Droga: Placebo
Receipt of tablet with placebo by mouth every day for 4 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year
Periodo de tiempo: Baseline (Day 1) to 12 months
Baseline (Day 1) to 12 months

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Second Affiliated Hospital, School of Medicine, Zhejiang University

Colaboradores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de mayo de 2029

Finalización del estudio (Estimado)

1 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026-0378

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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