Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Intensive Care Unit; Pneumocystis Jiroveci Pneumonia

Study type: Observational

Funder types: Other

Identifiers

NCT03201497

PJP2017-1

Details and patient eligibility

About

the investigators aim to set up a multicenter registry study for severe PJP requiring ICU admission. The purpose of this study is

1. to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes.
2. to explore the predictive factors associated with outcomes ;
3. to compare the difference between PJP patients with HIV and without HIV infection.

Full description

Pneumocystis jiroveci pneumonia (PJP) is a common opportunistic infection in immunocompromised patients. Although the mortality of patients with mild to moderate PJP has declined substantially, the reported outcomes of severe PJP requiring ICU admission, especially with mechanical ventilation are grave. The data on this group of patients is very limited and mainly comes from retrospective studies.

the investigators aim to set up a multicenter registry study for patient with severe PJP requiring ICU admission to provide comprehensive descriptive data on diagnosis, clinical course, critical care management and outcomes in a large cohort.

All patients with PJP admitted to the participating ICU during a two-year period will be enrolled. The CRF will be made available to the participating sites as a printable paper-based CRF.

The following individual patient data for study participants will be collected:

• General demographic information
• Presence of risk factors for PJP and comorbid condition
• use of prophylactic SMZ/TMP, immunosuppressive medications prior to ICU admission
• Information about PJP and co-infection diagnosis
• vital signs, laboratory(blood serum and BALF sample) and radiologic data at ICU admission and during ICU stay
• organ failures and severity of the disease at admission, new onset of organ failures during ICU stay
• Medications for PJP, time course and modalities and settings for respiratory support
• ICU, 28-day mortality, hospital, 90-day mortality

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis with PJP, confirmed by PCR or methenamine silver stain of sample from BALF, aspirate or sputum;
• ICU admission due to PJP-related respiratory failure

Exclusion criteria

• NO

Trial design

300 participants in 1 patient group

patients with PJP

Description:

PJP patients in ICU with or without HIV infection