Development and Validation of (Bio)Sensors for the Identification of Pathogens

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The recent COVID-19 pandemic has revealed the need to develop tests that are accurate, rapid, and inexpensive for the diagnosis of infectious diseases. This problem is relevant not only for viruses, but also for bacteria and parasites: the identification of pathogens at low concentrations by simple and accurate methods is still largely unsatisfied because these microorganisms are structurally complex and are incorporated in composite and diverse biological samples, which can create relevant interferences in pathogens' detection. Direct diagnostic approaches, such as microscopic examination, culture and molecular testing are carried out in equipped laboratories and require long waiting times to obtain the results. Recently developed point-of-care (POC) tests are a group of technologies that miniaturize tests into portable devices such that they can be performed both in well-equipped laboratories and outside the conventional laboratory setting. The present study aims to explore the feasibility and adaptability of newly developed platforms to detect: 1. a virus (SARS-CoV2), 2. a bacterium (Pseudomonas aeruginosa) and 3. a protozoan parasite (Leishmania infantum) in clinical specimens, such as blood and respiratory samples. These newly developed platforms are expected to overcome the current limitations of molecular testing (high cost, time required and need for well-equipped laboratories) and rapid testing (high number of false-negative results). In addition, the newly developed platforms may have important clinical application in low-income countries, which will benefit from a simple and inexpensive approach to detect the many infectious diseases that affect millions of people each year.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Obtaining informed consent

• Age ≥ 18 years

• Patients who meet one of the following conditions: SARS-CoV2 positive patients (group 1), SARS-CoV2 negative patients (group 2), P. aeruginosa positive patients (group 3), P. aeruginosa negative patients (group 4), L. infantum positive patients (group 5), L. infantum negative patients (group 6).

Locations
Other Locations
Italy
Department of Medical and Surgical Sciences, University of Bologna
RECRUITING
Bologna
Contact Information
Primary
Stefania Varani, MD, PhD
stefania.varani@unibo.it
+39 0512143013
Backup
Luca Prodi, PhD
luca.prodi@unibo.it
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2025-11-02
Participants
Target number of participants: 200
Treatments
SARS-CoV2 positive patients
Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort.
SARS-CoV2 negative patients
Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort.
P. aeruginosa positive patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
P. aeruginosa negative patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
L. infantum positive patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
L. infantum negative patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
Sponsors
Leads: University of Bologna

This content was sourced from clinicaltrials.gov