Using PCR to detect malaria, Leishmania, and Pneumocystis infections
Official title: Introduzione Della Polymerase Chain Reaction (PCR) in Microbiologia e Parassitologia
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07269314 · Data updated 2026-11-12
This project will test whether PCR can more quickly and accurately detect malaria, Leishmania, and Pneumocystis in patient samples.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07269314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with suspected or confirmed malaria, Leishmania, or Pneumocystis infections whose blood, bone marrow, or tissue samples can be submitted for laboratory testing.
✕Probably not a fit
Patients whose samples are unavailable, degraded, or of insufficient volume will not be included and thus will not benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational pilot comparing routine microscopy and immunochromatographic assays with molecular PCR methods on retrospective and prospective clinical samples. The team will analyze Leishmania species, the five human Plasmodium species, and Pneumocystis jirovecii using commercial qualitative and multiplex PCR kits and quantitative approaches based on cycle threshold conversion. Selected samples will undergo DNA sequencing (p70 gene) for species and strain typing and PCR-based quantification of DNA load. Approximately 200–300 previously submitted and newly obtained samples of blood, bone marrow, and tissue will be tested at Fondazione IRCCS Policlinico San Matteo in Pavia.
Why it matters
Potential benefit: If successful, PCR-based testing could provide faster, more sensitive, and more specific diagnoses that support earlier and more targeted treatment.
How similar studies have gone: Previous studies have shown PCR improves sensitivity and species identification for malaria, leishmaniasis, and Pneumocystis, though quantification approaches and clinical implementation vary.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Stefania Paolucci
- Email: s.paolucci@smatteo.pv.it
- Phone: 0382502281
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.