Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

Study Overview
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Brief Summary
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the investigators aim to set up a multicenter registry study for severe PJP requiring ICU admission. The purpose of this study is to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes. to explore the predictive factors associated with outcomes ; to compare the difference between PJP patients with HIV and without HIV infection.

Detailed Description
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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

Official Title
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Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU

Conditions
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Pneumocystis Jiroveci Pneumonia, Intensive Care Unit

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with PJP<br>PJP patients in ICU with or without HIV infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day ICU mortality | 28 days mortality after ICU admission | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality | mortality at hospital discharge | Day 90 (censored at hospital discharge if discharge prior to Day 90) | 
| ICU length of stay | ICU length of stay at ICU discharge | Day 90 | 
| hospital length of stay | hospital length of stay at hospital discharge | Day 90 | 
| occurrence of SMZ/TMP treatment failure | 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) | day 7 after SMZ/TMP treatment | 
| mechanical ventilation free days | days without mechanical ventilation during ICU | day 28 | 
| occurrence of non-invasive mechanical ventilation | 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 | day 28 | 
| occurrence of pneumothorax or pneumomediastinum | pneumothorax or pneumomediastinum is confirmed by chest X ray or CT | day 28 | 
| ICU acquired infectious disease | incidence of pulmonary of extra-pulmonary infections. Diagnosis of infections disease will be defined by the need of treatment. | day 28 |