PCP in Immunocompromised Population in Southern China

Recruiting

• Conditions: Polymerase Chain Reaction; Diagnosis; Immunocompromised Patients; Pneumocystis Pneumonia
• Interventions: Diagnostic Test: PCR was used to detect pneumocystis in respiratory specimens

• Registration Number: NCT05605145
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

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.

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 Timeline

• Study Start: 2021-05-12
• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunocompromised patients	PCR was used to detect pneumocystis in respiratory specimens	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.

Primary Outcome Measures

Name	Time	Method
PJP diagnosis rate	1 week	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).

Secondary Outcome Measures

Name	Time	Method
Treatment response rate of PJP	3 months	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.
Overall Survival rate	3 months	Survival was defined as being alive 3 months after symptoms onset.

Trial Locations

Locations (1)

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China