Clinical trial NCT05605145: PCP in Immunocompromised Population in Southern China
Official title: Pneumocystis Pneumonia in Immunocompromised Population in Southern China：A Multicenter,Open,Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunocompromised Patients
Pneumocystis Pneumonia
Diagnosis
Polymerase Chain Reaction
Keywords: Pneumocystis Pneumonia
Immunocompromised Patients
Polymerase Chain Reaction
Treatment
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Guangxi Zhuang Autonomous Region
name: The Fourth People's Hospital of Nanning
name: Chest Hospital of Guangxi Zhuang Autonomous Region
name: People's Hospital of Baise
name: LiuZhou People's Hospital
name: The second Nanning People's Hospital
name: The People's Hospital of Wuzhou
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Second Affiliated Hospital of Guangzhou Medical University
name: 923rd Hospital of the People's Liberation Army
First posted: 2022-11-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Immunocompromised patients who have fever, respiratory symptoms or pulmonary imaging changes were recruited into group.Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from enrolled patients and detected for pneumocystis by the combined detection system including qPCR and/or mNGS.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PJP diagnosis rate
timeFrame: 1 week
Secondary outcomes:
measure: Treatment response rate of PJP
timeFrame: 3 months
measure: Overall Survival rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Cunwei Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: