Clinical trial NCT06548841: Development and Validation of (Bio)Sensors for the Identification of Pathogens
Official title: Development and Validation of (Bio)Sensors for the Identification of Pathogens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections
Infection, Bacterial
Infection Viral
Infection, Parasite
SARS CoV 2 Infection
Pseudomonas Aeruginosa Infection
Leishmania Infantum Disease
Keywords: infections
platform
nanobiotechnological platforms
bacterial
viral
protozoan
diagnostic
point of care test
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: patients with SARS-CoV2 infection. Group 2: patients without SARS-CoV2 infection. Group 3: patients with P. aeruginosa infection. Group 4: patients without P. aeruginosa infection. Group 5: patients with L. infantum infection. Group 6: patients without L. infantum infection.

Brief 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 criteria: 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

Primary outcomes:
measure: The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of Medical and Surgical Sciences, University of Bologna
Study officials:
affiliation: University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Tiziana Lazzarotto, PhD
role: PRINCIPAL_INVESTIGATOR
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