Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission

June 28, 2017 updated by: Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
patients with PJP
PJP patients in ICU with or without HIV infection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
28-day ICU mortality
Time Frame: Day 28
28 days mortality after ICU admission
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: Day 90
ICU length of stay at ICU discharge
Day 90
hospital mortality
Time Frame: Day 90 (censored at hospital discharge if discharge prior to Day 90)
mortality at hospital discharge
Day 90 (censored at hospital discharge if discharge prior to Day 90)
hospital length of stay
Time Frame: Day 90
hospital length of stay at hospital discharge
Day 90
occurrence of SMZ/TMP treatment failure
Time Frame: day 7 after SMZ/TMP treatment
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
Time Frame: day 28
days without mechanical ventilation during ICU
day 28
occurrence of non-invasive mechanical ventilation
Time Frame: day 28
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
Time Frame: day 28
pneumothorax or pneumomediastinum is confirmed by chest X ray or CT
day 28
ICU acquired infectious disease
Time Frame: day 28
incidence of pulmonary of extra-pulmonary infections. Diagnosis of infections disease will be defined by the need of treatment.
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bin Du, Dr, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intensive Care Unit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings