A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After… (NCT05077150) | Clinical Trial Compass
CompletedNot Applicable
A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT
Belgium, France, Germany168 participantsStarted 2016-03
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria PCP cases:
* 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
Exclusion Criteria PCP cases:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is completed and was looking at risk factors for Pneumocystis pneumonia after allogeneic stem cell transplant, has any of that research changed the way you decide who needs preventive treatment or monitoring after transplant?
2This trial used PCR testing to help identify PCP infections — is PCR testing something you already use in my care plan, and how might it affect how quickly a PCP infection could be caught in my case?
3Because this was a case-control study rather than a treatment trial, it was designed to identify patterns in who got PCP rather than to test a new drug — does that mean the findings are more about guiding prevention strategies, and how does that apply to my specific situation after transplant?
4Given that this study focused on timing of PCP infections after allogeneic HSCT, is there a particular window post-transplant when you'd consider me most at risk, and what precautions would you recommend during that period?
5Are there published results from this completed study that might help us decide how long I should stay on PCP prophylaxis after my transplant, or whether my specific risk factors put me in a higher-risk group?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-transplant risk factors for PCP infection
Timeframe: 90 days
Trial details
NCT IDNCT05077150
SponsorEuropean Society for Blood and Marrow Transplantation