PCP in Immunocompromised Population in Southern China

NCT05605145 | Unknown DMC

• 1 other identifier: GX-PCP-2020
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.

Conditions

Immunocompromised Patients; Pneumocystis Pneumonia; Diagnosis; Polymerase Chain Reaction

Keywords

Pneumocystis Pneumonia; Immunocompromised Patients; Polymerase Chain Reaction; Treatment

Outcome Measures

Primary Outcomes (1)

• PJP diagnosis rate

  Proven pneumocystis jirovecii pneumonia（PJP）was defined as direct microscopy positive finding of a bronchopulmonary specimen. The diagnosis of probable PJP was applied to patients with a positive qPCR or metagenomic Next-Generation Sequencing（mNGS）and several criteria including an underlying immunosuppressive condition, clinical symptoms and radiological signs deemed to be compatible with PJP by clinicians. Pneumocystis jirovecii colonization was defined as any case presented with a positive qPCR or mNGS, which was not included in the previous two groups. Non-PjP corresponded to a negative Pj result by the above detection method(direct microscopy,qPCR or mNGS).

  1 week

Secondary Outcomes (2)

• Treatment response rate of PJP

  3 months

• Overall Survival rate

  3 months

Study Arms (1)

Immunocompromised patients

1. Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease. 2. Typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia. 3. Radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT). 4. Respiratory tract samples were collected for qPCR and/or mNGS detection.

Diagnostic Test: PCR was used to detect pneumocystis in respiratory specimens

Interventions

PCR was used to detect pneumocystis in respiratory specimens DIAGNOSTIC_TEST

Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from all patients who met the enrollment conditions of this study. qPCR and/or mNGS were used to detect pneumocystis in respiratory specimens.

Immunocompromised patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Immunocompromised patients who have fever, respiratory symptoms or pulmonary imaging changes were recruited into group.Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from enrolled patients and detected for pneumocystis by the combined detection system including qPCR and/or mNGS.

You may qualify if:

• Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease.
• Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
• Patients with radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
• Respiratory tract samples were collected for qPCR and/or mNGS detection.

You may not qualify if:

• Patients who were unable to obtain a respiratory specimen.
• Medical record was incomplete.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• The Fourth People's Hospital of Nanning: collaborator
• Chest Hospital of Guangxi Zhuang Autonomous Region: collaborator
• People's Hospital of Baise: collaborator
• LiuZhou People's Hospital: collaborator
• The second Nanning People's Hospital: collaborator
• The People's Hospital of Wuzhou: collaborator
• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• 923rd Hospital of the People's Liberation Army: collaborator

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from all patients who met the enrollment conditions of this study.

MeSH Terms

Conditions

Pneumonia, Pneumocystis; Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cunwei Cao, MD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cunwei Cao, MD

CONTACT

+86-13978608798; caocunwei@yeah.net

Meiqing Wu, MD

CONTACT

+86-15978184767; 453433378@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 4, 2022
• Study Start: May 12, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)