PCP in Immunocompromised Population in Southern China

First Affiliated Hospital of Guangxi Medical University300 enrolled

Overview

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

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

300

Conditions

Immunocompromised Patients Pneumocystis Pneumonia Diagnosis Polymerase Chain Reaction

Interventions

PCR was used to detect pneumocystis in respiratory specimensDIAGNOSTIC_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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 1 week

Secondary Outcomes

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.

Time frame: 3 months

Overall Survival rate

Survival was defined as being alive 3 months after symptoms onset.

Time frame: 3 months

Central Contacts

Cunwei Cao, MD

CONTACT

+86-13978608798 caocunwei@yeah.net

Meiqing Wu, MD

CONTACT

+86-15978184767 453433378@qq.com

Data from ClinicalTrials.gov

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