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Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03201497
Enrollment
300
Registered
2017-06-28
Start date
2017-07-01
Completion date
2019-08-01
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit, Pneumocystis Jiroveci Pneumonia

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

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
28-day ICU mortalityDay 2828 days mortality after ICU admission

Secondary

MeasureTime frameDescription
hospital mortalityDay 90 (censored at hospital discharge if discharge prior to Day 90)mortality at hospital discharge
ICU length of stayDay 90ICU length of stay at ICU discharge
hospital length of stayDay 90hospital length of stay at hospital discharge
occurrence of non-invasive mechanical ventilationday 28Non-invasive mechanical ventilation failure is defined as need for switch from non-invasive mechanical ventilation to invasive mechanical ventilation due to deteriorated respiratory failure
mechanical ventilation free daysday 28days without mechanical ventilation during ICU
occurrence of pneumothorax or pneumomediastinumday 28pneumothorax or pneumomediastinum is confirmed by chest X ray or CT
ICU acquired infectious diseaseday 28incidence of pulmonary of extra-pulmonary infections. Diagnosis of infections disease will be defined by the need of treatment.
occurrence of SMZ/TMP treatment failureday 7 after SMZ/TMP treatmentSMZ/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)

Contacts

Primary Contactjinmin Peng, Dr.
pjm731@hotmail.com86-010-69155036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026