Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission
- Conditions
- Intensive Care UnitPneumocystis Jiroveci Pneumonia
- Registration Number
- NCT03201497
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- NO
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28-day ICU mortality Day 28 28 days mortality after ICU admission
- Secondary Outcome Measures
Name Time Method ICU length of stay Day 90 ICU length of stay at ICU discharge
occurrence of pneumothorax or pneumomediastinum day 28 pneumothorax or pneumomediastinum is confirmed by chest X ray or CT
mechanical ventilation free days day 28 days without mechanical ventilation during ICU
hospital mortality Day 90 (censored at hospital discharge if discharge prior to Day 90) mortality at hospital discharge
hospital length of stay Day 90 hospital length of stay at hospital discharge
occurrence of SMZ/TMP treatment failure day 7 after SMZ/TMP treatment SMZ/TMP treatment failure is defined as worsening P/F or radiographic features with a requirement for an increased respiratory support after 7 days of SMZ/TMP treatment (SMZ/TMP)
occurrence of non-invasive mechanical ventilation day 28 Non-invasive mechanical ventilation failure is defined as need for switch from non-invasive mechanical ventilation to invasive mechanical ventilation due to deteriorated respiratory failure
ICU acquired infectious disease day 28 incidence of pulmonary of extra-pulmonary infections. Diagnosis of infections disease will be defined by the need of treatment.