Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology (NCT07269314) | Clinical Trial Compass
RecruitingNot Applicable
Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology
Italy200 participantsStarted 2023-09-01
Plain-language summary
The goal is to develop molecular systems to support or replace in microscopic characterization and in vitro tests with molecular biology systems capable of improving performance in parasitology tests. In particular, we will analyze the main pathogens: several Leishmania species (Old and New World Leishmania species), the five Plasmodium species of human interest (falciparum, oval, vivax, malariae and knowlesi) and Pneumocistys jiroveci, using molecular methods based on the speed, specificity and sensitivity necessary for their diagnosis. Furthermore, we want to provide specific elements for the typing of the species. Our aim is to improve diagnostic and specie classification methods by using PCR in microbiology and parasitology, to evaluate its impact on diagnosis. We would evaluate the impact of this method in terms of timing, sensitivity and specificity of diagnosis. We would also explore future possibilities on quantification techniques, in order to support the clinician to evaluate the efficacy of therapy during the follow-up.
Furthermore, we would evaluate these methods in terms of cost effectiveness towards classical direct methods, which are now operator-dependent.
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:
Approximately 200-300 samples retrospectively submitted to the laboratory for the study in question, for the detection of P. jirovecii, Plasmodium Malaria and Leishmania tested with the classical method.
Exclusion Criteria:
Samples that are unsuitable due to storage errors and/or insufficient volume will be 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.
1This study is testing PCR as a diagnostic tool for infections like malaria, Pneumocystis, and Leishmania — does my situation involve one of these conditions, and could a more accurate PCR-based diagnosis actually change my treatment plan?
2Since this trial doesn't have a traditional phase number, it sounds more like a diagnostic or laboratory study rather than a treatment trial — what does that mean for me practically, and would participating involve any changes to how I'm treated or just how I'm tested?
3The study is specifically measuring a Pneumocystis PCR test as its main outcome — if Pneumocystis is a concern in my case, how does PCR compare to the standard tests I might already be getting, and is there any risk or benefit to me in having this additional test done?
4Given that this trial is listed as currently recruiting, would enrolling affect the timeline of my diagnosis or care in any way, and are there logistical things I should know about what participating actually involves day to day?
5Are there standard diagnostic approaches already available for my specific infection — malaria, Pneumocystis, or Leishmania — that my care team would recommend before or instead of participating in a research study like this one?
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
Pneumocystis PCR test
Timeframe: From January 2024 to september 2025
Trial details
NCT IDNCT07269314
SponsorFondazione IRCCS Policlinico San Matteo di Pavia