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

December 3, 2025 updated by: Tiziana Lazzarotto, University of Bologna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40138
        • Department of Medical and Surgical Sciences, University of Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV2 positive patients
Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.
SARS-CoV2 negative patients
Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.
P. aeruginosa positive patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.
P. aeruginosa negative patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.
L. infantum positive patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.
L. infantum negative patients
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

  1. The first type of nanobiotechnological platform encompasses the hybridization of pathogen nucleic acids - that may be present in the clinical specimen - by employing specific molecular probes.
  2. The second type of nanobiotechnological platform encompasses the use of capture bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral particles (in the case of SARS-CoV2) and the use of reporter bacteriophages ("transducer Phages") for the transduction of the electrochemiluminescent signal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests
Time Frame: 16 months

The sensitivity and the specificity will be estimated by creating the confusion matrix corresponding to the classification between signals significant (beyond Limit Of Detection, LOD) and samples giving non-significant signals (below LOD).

Where the analytical problem is described by other variables than the electrochemiluminescent analytical signal, multivariate classification methods shall be applied. The correlation and interaction between variables will also be estimated.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Tiziana Lazzarotto, PhD, University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECLIPSE (Rakuten Medical)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Shared IPD will not include personal data, but will be limited to positive or negative test results to a specific pathogen by employing routine diagnostics techniques and the new devices.

IPD Sharing Time Frame

Summary data will be published starting 6 months after the end of the study.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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