AzTrials
AzTrials

Malaria, Pneumocystis, LeishmaniaNCT07269314

Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology

An observational study of Malaria, Pneumocystis, Leishmania, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Malaria, Pneumocystis, Leishmania
How many people
200 participants
Where
1 siteItaly
Study dates
1 Sep 2023to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: Positive samples for Leishmania amastygotes in peripheral blood and/or bone marrow aspirate/biopsy and/or from cutaneous scraping/biopsy previously tested according to routine diagnostic assays 2-Plasmodium species blood positive samples tested for and analyzed by direct microscopy and immunocromatographic assay, 3-Pneumocistis jirovecii in positive BAL or bronchoaspirate (BAS) samples obtained by direct microscopy

Who may be able to join

  • 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.

Who cannot join

  • Samples that are unsuitable due to storage errors and/or insufficient volume will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stefania Paolucci contact

0382502281

s.paolucci@smatteo.pv.it

Italy1 site, 1 recruiting
  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

    Stefania Paolucci, 0382502281, s.paolucci@smatteo.pv.it

    Recruiting

Other trials in Italy

About this study

Official title: Introduzione Della Polymerase Chain Reaction (PCR) in Microbiologia e Parassitologia

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.

Read the detailed description

Our project is an observational retrospective and prospective cross-sectional diagnostic pilot study, about the comparison between standard routine laboratory tests and new molecular biology assays. In particular, we would detect principal pathogen Leishmania species (Old and New World Leishmania species), the five species of Plasmodium of human interest (falciparum, oval, vivax, malaria and knowlesi) and Pneumocistys jiroveci,

  1. Positive samples for Leishmania amastygotes in peripheral blood and/or bone marrow aspirate/biopsy and/or from cutaneous scraping/biopsy previously tested according to routine diagnostic assays will be tested with a specific qualitative PCR analysis by using commercial diagnosis kit. In addition, we would perform a system of DNA quantification using PCR cycle threshold of the single sample and a virtual scale able to convert the results in the DNA load (Piralla A et al, J clin virol 2013). Then we would perform a specific DNA sequencing of p70 gene to determine specie and the strain.
  2. Plasmodium species blood positive samples tested for and analyzed by direct microscopy and immunocromatographic assay, will be tested with multiplex PCR commercial diagnostic kit or with a described method (A.Berg et al, Infection 2020) able to determine single or mixed infection and to quantify the parasitemia respectively. In detail, the blood samples will be analyzed with qualitative and quantitative PCR analysis for Plasmodium spp and Plasmodium Falciparum, respectively. The concentration of P. falciparum DNA in blood samples will be measured by quantitative real-time PCR (qPCR) as described elsewhere (Imwong M, J.clin.microb 2014). In Plasmodium falciparum positive samples, the amount of DNA copies obtained from each sample will be compared with the level of parasitemia obtained from direct microscopy analysis. In this way we would like to determine a range of DNA copy values comparable to the different degrees of classification that are currently obtained with percentages of red blood cells positive for the infection (<5% vs >5%). In this way, it could be possible to assess a level of parasitemia with quantitative PCR techniques.
  3. Finally, detection of Pneumocistis jirovecii in positive BAL or bronchoaspirate (BAS) samples obtained by direct microscopy will be reanalyzed by using PCR commercial diagnostic kit. As previously mentioned, the CT value will be converted in DNA load in comparison with direct microscopy data.
Medical subject headings
Malaria, Pneumonia, Pneumocystis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pneumocystis PCR test

    Primary endpoint will be the estimation of sensitivity of PCR tests in identifying the presence of main pathogens: Leishmania species, Plasmodium species and Pneumocistys jiroveci.

    Measured: From January 2024 to september 2025

Secondary outcomes (1)
  1. Malaria PCR test

    Secondary endpoint will be the comparison of the concentration of P. falciparum DNA in blood samples (measured by qPCR) according to parasitemia (>5% vs <5%).

    Measured: From genuary 2025 to september 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Other
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269314
Sponsor's protocol ID
P_41
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Malaria, Pneumocystis, Leishmania, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefania Paolucci (0382502281, s.paolucci@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pneumocystis PCR test (time frame: From January 2024 to september 2025). 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 8 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in