Clinical trial NCT03201497: Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission
Official title: Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumocystis Jiroveci Pneumonia
Intensive Care Unit
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PJP patients requiring ICU admission

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

Eligibility criteria: 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

Primary outcomes:
measure: 28-day ICU mortality
timeFrame: Day 28
Secondary outcomes:
measure: hospital mortality
timeFrame: Day 90 (censored at hospital discharge if discharge prior to Day 90)
measure: ICU length of stay
timeFrame: Day 90
measure: hospital length of stay
timeFrame: Day 90
measure: occurrence of SMZ/TMP treatment failure
timeFrame: day 7 after SMZ/TMP treatment
measure: mechanical ventilation free days
timeFrame: day 28
measure: occurrence of non-invasive mechanical ventilation
timeFrame: day 28
measure: occurrence of pneumothorax or pneumomediastinum
timeFrame: day 28
measure: ICU acquired infectious disease
timeFrame: day 28
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Bin Du, Dr
role: STUDY_DIRECTOR
References: