PCP in Immunocompromised Population in Southern China

NCT ID: NCT05605145

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-12

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Immunocompromised Patients Pneumocystis Pneumonia Diagnosis Polymerase Chain Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PCR was used to detect pneumocystis in respiratory specimens

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

The Fourth People's Hospital of Nanning

OTHER

Sponsor Role collaborator

Chest Hospital of Guangxi Zhuang Autonomous Region

UNKNOWN

Sponsor Role collaborator

People's Hospital of Baise

UNKNOWN

Sponsor Role collaborator

LiuZhou People's Hospital

OTHER

Sponsor Role collaborator

The second Nanning People's Hospital

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Wuzhou

UNKNOWN

Sponsor Role collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

923rd Hospital of the People's Liberation Army

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cunwei Cao, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Guangxi Medical University

Locations

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First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cunwei Cao, MD

Role: CONTACT

+86-13978608798

Meiqing Wu, MD

Role: CONTACT

+86-15978184767

Facility Contacts

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Cunwei Cao, MD

Role: primary

+86-13978608798

Meiqing Wu, MD

Role: backup

+86-15978184767

Other Identifiers

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GX-PCP-2020

Identifier Type: -

Identifier Source: org_study_id

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