PCP in Immunocompromised Population in Southern China (PCP)

Pneumocystis Pneumonia in Immunocompromised Population in Southern China：A Multicenter,Open,Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Diagnosis; Polymerase Chain Reaction; Immunocompromised Patients; Pneumocystis Pneumonia
• Intervention / Treatment: Diagnostic test: PCR was used to detect pneumocystis in respiratory specimens

Detailed Description

Pneumocystis jirovecii pneumonia (PJP) is a serious opportunistic infection in immunocompromised patients, with a difficult diagnosis, rapid progression and high mortality rate. The PJP mortality rate is high among patients with delayed diagnosis and treatment, and death is due to severe respiratory failure. Up to now, data regarding Pneumocystis jirovecii infection in immunocompromised patients is limited. In the present prospective study, the investigators aimed to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Cunwei Cao, MD; Phone Number: +86-13978608798; Email: caocunwei@yeah.net
• Study Contact Backup: Name: Meiqing Wu, MD; Phone Number: +86-15978184767; Email: 453433378@qq.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 510515
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University
      • Contact: Cunwei Cao, MD; Phone Number: +86-13978608798; Email: caocunwei@yeah.net
      • Contact: Meiqing Wu, MD; Phone Number: +86-15978184767; Email: 453433378@qq.com
      • Sub-Investigator: Han Li, MD
      • Sub-Investigator: Shaoyong Xi, MD
      • Sub-Investigator: Xiuwen Tang, MD
      • Sub-Investigator: Weier Huang, MD
      • Sub-Investigator: Wenfei Wei, MD
      • Sub-Investigator: Xuri Jie, MD
      • Sub-Investigator: Longhua Li, MD
      • Sub-Investigator: Huiping Huang, MD
      • Sub-Investigator: Yinghui Lai, MD
      • Sub-Investigator: Hongliang Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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. Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
3. Patients with 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Immunocompromised patients; 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.; Typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.; 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.

Diagnostic test: PCR was used to detect pneumocystis in respiratory specimens; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response rate of PJP	Treatment response was defined as one of the followings: (1)amelioration or resolution of baseline signs and symptoms, chest computed tomography (CT), and hospital discharge; (2)clinical improvement sustained at least 2 to 4 weeks after cessation of antifungal therapy.	3 months
Overall Survival rate	Survival was defined as being alive 3 months after symptoms onset.	3 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Collaborators: Second Affiliated Hospital of Guangzhou Medical University; LiuZhou People's Hospital; The Fourth People's Hospital of Nanning; The People's Hospital of Guangxi Zhang Autonomous Region; Chest Hospital of Guangxi Zhuang Autonomous Region; People's Hospital of Baise; The second Nanning People's Hospital; The People's Hospital of Wuzhou; Maternal and Child Health Care of Guangxi Zhuang Autonomous Region; 923rd Hospital of the People's Liberation Army
• Investigators: Principal Investigator: Cunwei Cao, MD, First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Polymerase Chain Reaction; Pneumocystis Pneumonia; Immunocompromised Patients
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal; Pneumocystis Infections; Pneumonia; Pneumonia, Pneumocystis
• Other Study ID Numbers: GX-PCP-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No