Pneumocystis Jirovecii InfectionJIROVECINCT06173453
Factors Associated With Survival in Patients Having Pneumocystis Jirovecii
An observational study of Pneumocystis Jirovecii Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Jirovecii Infection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 10 Oct 2025
- 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: Adult patients with a positive respiratory sample for P. jirovecii
Who may be able to join
- Adult patients with a positive respiratory sample for P. jirovecii cared for in Strasbourg University Hospitals between 01/01/2016 and 31/12/2018. Positive samples are defined as a direct examination finding cysts or trophozoites after staining with May-Grunewald-Giemsa and/or Gomori-Grocott, a positive P. jirovecii PCR on sputum, tracheal aspirates or bronchial fluid -alveolar
- Subject not objecting to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
François DANION, MD, 33 3 69 55 15 88, francois.danion@chru-strasbourg.fr
François DANION, MD
About this study
Official title: Factors Associated With Survival in Patients With a Positive Sample for Pneumocystis Jirovecii at the Strasbourg University Hospital: a Retrospective Study From 2016 to 2018
Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients.
Pneumocystosis was mainly linked to HIV in the 1990s, but with the advent of new immunosuppressive molecules used in cancers or autoimmune diseases and with the increase in the number of transplants, the epidemiology has changed in recent years.
Studies on P. jirovecii-related mortality are only based on patients with pneumocystosis. As a result, patients who are simply colonized or patients who are sick but not treated are not taken into account in these studies. The investigators therefore wish to study the overall mortality at six weeks and at three months in all patients with a positive sample for P. jirovecii
- Conditions
- Pneumocystis Jirovecii Infection
- Keywords
- P jirovecii Infection, Pneumocystis Infections, Pneumocystis jirovecii Infection, Pneumocystis jirovecii, Pneumonia, Pneumocystis
- Medical subject headings
- Pneumocystis Infections, Pneumonia, Pneumonia, Pneumocystis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at six weeks and three months after infection
Measured: six weeks after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2023
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jirovecii InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173453
- Sponsor's protocol ID
- 8722
- Acronym
- JIROVECI
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Survival in Patients With a Positive Sample for Pneumocystis Jirovecii at the Strasbourg University Hospital: a Retrospective Study From 2016 to 2018
- ClinicalTrials.gov ID
- NCT06173453
- Acronym / sponsor ID
- JIROVECI / 8722
- Conditions
- Pneumocystis Jirovecii Infection
- Keywords
- P jirovecii Infection, Pneumocystis Infections, Pneumocystis jirovecii Infection, Pneumocystis jirovecii, Pneumonia, Pneumocystis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 15 Dec 2023 (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.
Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients.
Pneumocystosis was mainly linked to HIV in the 1990s, but with the advent of new immunosuppressive molecules used in cancers or autoimmune diseases and with the increase in the number of transplants, the epidemiology has changed in recent years.
Studies on P. jirovecii-related mortality are only based on patients with pneumocystosis. As a result, patients who are simply colonized or patients who are sick but not treated are not taken into account in these studies. The investigators therefore wish to study the overall mortality at six weeks and at three months in all patients with a positive sample for P. jirovecii
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a positive respiratory sample for P. jirovecii
Key inclusion criteria (2 listed)
- Adult patients with a positive respiratory sample for P. jirovecii cared for in Strasbourg University Hospitals between 01/01/2016 and 31/12/2018. Positive samples are defined as a direct examination finding cysts or trophozoites after staining with May-Grunewald-Giemsa and/or Gomori-Grocott, a positive P. jirovecii PCR on sputum, tracheal aspirates or bronchial fluid -alveolar
- Subject not objecting to the reuse of their data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
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
Survival at six weeks and three months after infection
Time frame: six weeks after infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Jirovecii Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 François DANION, MD (33 3 69 55 15 88, Francois.danion@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at six weeks and three months after infection (time frame: six weeks after infection). 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 15 Dec 2023.