Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU

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.

Study Overview

• Status: Unknown
• Conditions: Intensive Care Unit; Pneumocystis Jiroveci Pneumonia

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

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: jinmin Peng, Dr.; Phone Number: 86-010-69155036; Email: pjm731@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PJP patients requiring ICU admission

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with PJP; PJP patients in ICU with or without HIV infection

What is the study measuring?

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
ICU length of stay	ICU length of stay at ICU discharge	Day 90
hospital mortality	mortality at hospital discharge	Day 90 (censored at hospital discharge if discharge prior to 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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Bin Du, Dr, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (ACTUAL): June 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal; Pneumocystis Infections; Pneumonia; Pneumonia, Pneumocystis
• Other Study ID Numbers: PJP2017-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No