Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

Intensive Care Unit Clinical Trial

Official title:

Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03201497
• Other study ID #: PJP2017-1
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 28, 2017
• Start date: July 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: June 2017
• Source: Peking Union Medical College Hospital
• Contact: jinmin Peng, Dr.
• Phone: 86-010-69155036
• Email: pjm731[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Intensive Care Unit
• Pneumocystis Jiroveci Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day ICU mortality	28 days mortality after ICU admission	Day 28
Secondary	hospital mortality	mortality at hospital discharge	Day 90 (censored at hospital discharge if discharge prior to Day 90)
Secondary	ICU length of stay	ICU length of stay at ICU discharge	Day 90
Secondary	hospital length of stay	hospital length of stay at hospital discharge	Day 90
Secondary	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
Secondary	mechanical ventilation free days	days without mechanical ventilation during ICU	day 28
Secondary	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
Secondary	occurrence of pneumothorax or pneumomediastinum	pneumothorax or pneumomediastinum is confirmed by chest X ray or CT	day 28
Secondary	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