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

University of Bologna

Status: Completed

Conditions: SARS CoV 2 Infection; Pseudomonas Aeruginosa Infection; Infection, Parasite; Infection Viral; Leishmania Infantum Disease; Infections; Infection, Bacterial

Treatments: Other: Nanobiotechnology platforms

Study type: Observational

Funder types: Other

Identifiers

NCT06548841

ECLIPSE

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• None

Trial design

149 participants in 6 patient groups

SARS-CoV2 positive patients

Description:

Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort.

Treatment:

Other: Nanobiotechnology platforms

SARS-CoV2 negative patients

Description:

Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort.

Treatment:

Other: Nanobiotechnology platforms

P. aeruginosa positive patients

Description:

Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.

Treatment:

Other: Nanobiotechnology platforms

P. aeruginosa negative patients

Description:

Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.

Treatment:

Other: Nanobiotechnology platforms

L. infantum positive patients

Description:

Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.

Treatment:

Other: Nanobiotechnology platforms

L. infantum negative patients

Description:

Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.

Treatment:

Other: Nanobiotechnology platforms