Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pn… (NCT06431958) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii
France300 participantsStarted 2024-06-01
Plain-language summary
The main objective of the proposed research is to identify Pneumocystis jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii.
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:
* Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample)
* No opposition
* Patient affiliated to a social security system
Exclusion Criteria:
* Patients under legal protection (guardianship, curatorship)
* Refusal to participate
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.
1This trial is studying whether certain strains of Pneumocystis jirovecii carry genetic mutations that might make them resistant to standard treatments — could testing my specific strain for these resistance-linked SNPs change how my doctor would approach treating my Pneumocystis pneumonia?
2Since this trial is no longer actively recruiting, are there other ways I could access ddPCR or biosensor-based resistance testing for Pneumocystis jirovecii outside of this study, or is this technology still only available in research settings?
3The trial is listed as 'Phase NA,' which suggests it's a diagnostic or observational study rather than a treatment trial — does that mean my care wouldn't change based on what the test finds, and if resistance mutations were detected in my sample, what treatment options would actually be available to me?
4Standard treatment for Pneumocystis pneumonia relies on drugs like TMP-SMX, and this trial is looking for resistance to those kinds of treatments — if my infection turned out to carry one of these resistance-associated mutations, what alternative treatments would my doctor consider, and how well-studied are those alternatives?
5If my doctor thinks this kind of resistance testing could be relevant to my case, are there institutions or labs already using ddPCR-based Pneumocystis resistance detection outside of a clinical trial that I could be referred to?
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
Presence of specific strains of Pneumocystis jirovecii potentially resistant to treatments in patients infected with this fungus