Pneumocystis PneumoniaNCT05077150
A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT
An observational study of Pneumocystis Pneumonia, run by European Society for Blood and Marrow Transplantation at 9 sites in 6 countries.
Trial summary
The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumocystis Pneumonia
- How many people
- 168 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Mar 2016to May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have received an allogeneic HSCT during the last 24 months and who have a BAL fluid positive for Pneumocystis jirovecii (qPCR or IF or cytology) during the study period will be included, irrespectively of age, transplant characteristics and irrespectively to the fact that the patient has been treated for PcP or not. Assuming an incidence of 3% after allogeneic HSCT, a total number of 3 300 allogeneic transplant (roughly 100 centers) would allow to expect 100 cases of PcP.
Who may be able to join
- Allogeneic HSCT within the previous 24 months
- New case (first onset) of PcP documented in a BAL fluid, whatever the positive diagnostic test (cytology or IF or PCR) and whatever the presentation and treatment
- Any age
- Pre or post-transplant signed informed consent to enter the data in the EBMT registry
Who cannot join
- Autologous HSCT
- Allogeneic HSCT recipient transplanted more than 24 months at time of the onset of PcP
- Second episode of PcP since allogeneic HSCT (patients who had experienced PcP before the allogeneic HSCT are not excluded).
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
France4 sites
University of Amiens: CHU Amiens
Amiens, 80054
Hôpital Henri Mondor
Créteil, 94010
Hôpital Huriez
Lille, F-59037
Hopital St. Louis
Paris, 75475
About this study
The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.
Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.
Read the detailed description
Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. Knowing this is a non-interventional study, no additional visits or laboratory tests will be performed for the study. Only the available data will be collected.
- Conditions
- Pneumocystis Pneumonia
- Keywords
- jirovecii, pneumocystis, PCP
- 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 |
|---|---|---|
| PCP cases | Any allogeneic HSCT recipient who, during the 1-year study period, underwent a BAL from the day of transplant, and whose BAL fluid was positive for PcP: either by qPCR alone, or positive cytology or IF, irrespectively of clinical presentation, imaging, co-infection and PcP treatment. Only first episode of PcP will be included (incident cases). Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. | |
| Controls | Controls are matched to case on Centre and HSCT date and if possible on gender and date of birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant risk factors for PCP infection
To identify pre- and post-transplant factors associated with development of PcP after allogeneic HSCT including:
Underlying disease, graft versus host disease, relapse of underlying disease, immune status, co-infections, age
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study startMar 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis PneumoniaStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Blood and Marrow Transplantation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Christine Robin, MD, Principal investigator, Hematology Department, Pr Cordonnier. henri Mondor University HospitalSimone Cesaro, MD, Study chair, Paediatric Haematology Oncology. Policlinico G.B. Rossi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077150
- Sponsor's protocol ID
- (4)8414112
- Status last verified
- May 2023
- First submitted
- 6 Jan 2017
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT
- ClinicalTrials.gov ID
- NCT05077150
- Acronym / sponsor ID
- (4)8414112
- Conditions
- Pneumocystis Pneumonia
- Keywords
- jirovecii, pneumocystis, PCP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- European Society for Blood and Marrow TransplantationResearch network
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 14 Oct 2021 (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 fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.
Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.
Detailed description
Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. Knowing this is a non-interventional study, no additional visits or laboratory tests will be performed for the study. Only the available data will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCP cases | – | –Any allogeneic HSCT recipient who, during the 1-year study period, underwent a BAL from the day of transplant, and whose BAL fluid was positive for PcP: either by qPCR alone, or positive cytology or IF, irrespectively of clinical presentation, imaging, co-infection and PcP treatment. Only first episode of PcP will be included (incident cases). Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. |
| Controls | – | –Controls are matched to case on Centre and HSCT date and if possible on gender and date of birth. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have received an allogeneic HSCT during the last 24 months and who have a BAL fluid positive for Pneumocystis jirovecii (qPCR or IF or cytology) during the study period will be included, irrespectively of age, transplant characteristics and irrespectively to the fact that the patient has been treated for PcP or not. Assuming an incidence of 3% after allogeneic HSCT, a total number of 3 300 allogeneic transplant (roughly 100 centers) would allow to expect 100 cases of PcP.
Key inclusion criteria (4 listed)
- Allogeneic HSCT within the previous 24 months
- New case (first onset) of PcP documented in a BAL fluid, whatever the positive diagnostic test (cytology or IF or PCR) and whatever the presentation and treatment
- Any age
- Pre or post-transplant signed informed consent to enter the data in the EBMT registry
Key exclusion criteria (3 listed)
- Autologous HSCT
- Allogeneic HSCT recipient transplanted more than 24 months at time of the onset of PcP
- Second episode of PcP since allogeneic HSCT (patients who had experienced PcP before the allogeneic HSCT are not excluded).
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
Post-transplant risk factors for PCP infection
Time frame: 90 days
To identify pre- and post-transplant factors associated with development of PcP after allogeneic HSCT including: Underlying disease, graft versus host disease, relapse of underlying disease, immune status, co-infections, age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- 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.
Christine Robin, MD principal investigator
Hematology Department, Pr Cordonnier. henri Mondor University Hospital
Simone Cesaro, MD study chair
Paediatric Haematology Oncology. Policlinico G.B. Rossi
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Pneumonia, run by European Society for Blood and Marrow Transplantation at 9 sites in 6 countries.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium, Germany, Hungary, Israel and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplant risk factors for PCP infection (time frame: 90 days). 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 May 2023.