Pneumocystis Jiroveci PneumoniaNCT03201497
Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission
An observational study of Pneumocystis Jiroveci Pneumonia and Intensive Care Unit, run by Peking Union Medical College Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Jiroveci Pneumonia, Intensive Care Unit
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Aug 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PJP patients requiring ICU admission
Who may be able to join
- 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
Who cannot join
- NO
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes.
- to explore the predictive factors associated with outcomes ;
- to compare the difference between PJP patients with HIV and without HIV infection.
Read the 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
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with PJP | PJP patients in ICU with or without HIV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ICU mortality
28 days mortality after ICU admission
Measured: Day 28
Secondary outcomes (8)
hospital mortality
mortality at hospital discharge
Measured: Day 90 (censored at hospital discharge if discharge prior to Day 90)
ICU length of stay
ICU length of stay at ICU discharge
Measured: Day 90
hospital length of stay
hospital length of stay at hospital discharge
Measured: 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)
Measured: day 7 after SMZ/TMP treatment
mechanical ventilation free days
days without mechanical ventilation during ICU
Measured: 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
Measured: day 28
occurrence of pneumothorax or pneumomediastinum
pneumothorax or pneumomediastinum is confirmed by chest X ray or CT
Measured: 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.
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jiroveci PneumoniaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Du, Dr, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201497
- Sponsor's protocol ID
- PJP2017-1
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU
- ClinicalTrials.gov ID
- NCT03201497
- Acronym / sponsor ID
- PJP2017-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigators aim to set up a multicenter registry study for severe PJP requiring ICU admission. The purpose of this study is
- to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes.
- to explore the predictive factors associated with outcomes ;
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with PJP | – | –PJP patients in ICU with or without HIV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PJP patients requiring ICU admission
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- NO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day ICU mortality
Time frame: Day 28
28 days mortality after ICU admission
8 secondary outcomes
hospital mortality
Time frame: Day 90 (censored at hospital discharge if discharge prior to Day 90)
ICU length of stay
Time frame: Day 90
hospital length of stay
Time frame: Day 90
occurrence of SMZ/TMP treatment failure
Time frame: day 7 after SMZ/TMP treatment
mechanical ventilation free days
Time frame: day 28
occurrence of non-invasive mechanical ventilation
Time frame: day 28
occurrence of pneumothorax or pneumomediastinum
Time frame: day 28
ICU acquired infectious disease
Time frame: day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du, Dr study director
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Jiroveci Pneumonia and Intensive Care Unit, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinmin Peng, Dr. (86-010-69155036, pjm731@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day ICU mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.