PCP in Immunocompromised Population in Southern China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
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Patients with radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
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Respiratory tract samples were collected for qPCR and/or mNGS detection.
Exclusion Criteria:
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Patients who were unable to obtain a respiratory specimen.
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Medical record was incomplete.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China | 510515 |
Sponsors and Collaborators
- First Affiliated Hospital of Guangxi Medical University
- The People's Hospital of Guangxi Zhang Autonomous Region
- The Fourth People's Hospital of Nanning
- Chest Hospital of Guangxi Zhuang Autonomous Region
- People's Hospital of Baise
- LiuZhou People's Hospital
- The second Nanning People's Hospital
- The People's Hospital of Wuzhou
- Maternal and Child Health Care of Guangxi Zhuang Autonomous Region
- Second Affiliated Hospital of Guangzhou Medical University
- 923rd Hospital of the People's Liberation Army
Investigators
- Principal Investigator: Cunwei Cao, MD, First Affiliated Hospital of Guangxi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GX-PCP-2020