PCP in Immunocompromised Population in Southern China

Study Overview
=================
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.

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

Conditions
-----------------
Immunocompromised Patients, Pneumocystis Pneumonia, Diagnosis, Polymerase Chain Reaction

Intervention / Treatment
-----------------
* Diagnostic Test: PCR was used to detect pneumocystis in respiratory specimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia. Patients with 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. Exclusion Criteria: Patients who were unable to obtain a respiratory specimen. Medical record was incomplete.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunocompromised patients<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall Survival rate | Survival was defined as being alive 3 months after symptoms onset. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumocystis Pneumonia, Immunocompromised Patients, Polymerase Chain Reaction, Treatment