PCP in Immunocompromised Population in Southern China

Diagnosis Clinical Trial

— PCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605145
• Other study ID #: GX-PCP-2020
• Status: Recruiting
• Start date: May 12, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: Cunwei Cao, MD
• Phone: +86-13978608798
• Email: caocunwei[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Immunocompromised Patients
• Pneumocystis Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis
• Polymerase Chain Reaction

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (11)

Lead Sponsor

Collaborator

First Affiliated Hospital of Guangxi Medical University

923rd Hospital of the People's Liberation Army, Chest Hospital of Guangxi Zhuang Autonomous Region, LiuZhou People's Hospital, Maternal and Child Health Care of Guangxi Zhuang Autonomous Region, People's Hospital of Baise, Second Affiliated Hospital of Guangzhou Medical University, The Fourth People's Hospital of Nanning, The People's Hospital of Guangxi Zhang Autonomous Region, The People's Hospital of Wuzhou, The second Nanning People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival rate	Survival was defined as being alive 3 months after symptoms onset.	3 months