NCT03201497

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. 1.to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes.
  2. 2.to explore the predictive factors associated with outcomes ;
  3. 3.to compare the difference between PJP patients with HIV and without HIV infection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 26, 2017

Last Update Submit

June 28, 2017

Conditions

Pneumocystis Jiroveci PneumoniaIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 28-day ICU mortality

    28 days mortality after ICU admission

    Day 28

Secondary Outcomes (8)

  • hospital mortality

    Day 90 (censored at hospital discharge if discharge prior to Day 90)

  • ICU length of stay

    Day 90

  • hospital length of stay

    Day 90

  • occurrence of SMZ/TMP treatment failure

    day 7 after SMZ/TMP treatment

  • mechanical ventilation free days

    day 28

  • +3 more secondary outcomes

Study Arms (1)

patients with PJP

PJP patients in ICU with or without HIV infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PJP patients requiring ICU admission

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bin Du, Dr

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

jinmin Peng, Dr.

CONTACT

86-010-69155036pjm731@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 28, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

June 29, 2017

Record last verified: 2017-06