InfectionsNCT06548841
Development and Validation of (Bio)Sensors for the Identification of Pathogens
An observational study of Infections and Infection, Bacterial, run by University of Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Infection, Bacterial, Infection Viral
- What is being tested?
- Nanobiotechnology platforms
- How many people
- 149 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2024to 31 Oct 2025
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medical and Surgical Sciences, University of Bologna
Bologna, Bologna, 40138
About this study
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.
- Conditions
- Infections, Infection, Bacterial, Infection Viral, Infection, Parasite, SARS CoV 2 Infection, Pseudomonas Aeruginosa Infection
- Being tested
- Nanobiotechnology platforms
- Keywords
- infections, platform, nanobiotechnological platforms, bacterial, viral, protozoan, diagnostic, point of care test
- Medical subject headings
- Infections, Bacterial Infections, Virus Diseases, Parasitic Diseases, COVID-19, Pseudomonas Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanobiotechnology platformsOther
The analyses will be carried out using the novel devices, which are of two types:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV2 positive patients | Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort. Receives: Other: Nanobiotechnology platforms | |
| SARS-CoV2 negative patients | Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort. Receives: Other: Nanobiotechnology platforms | |
| P. aeruginosa positive patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort. Receives: Other: Nanobiotechnology platforms | |
| P. aeruginosa negative patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort. Receives: Other: Nanobiotechnology platforms | |
| L. infantum positive patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort. Receives: Other: Nanobiotechnology platforms | |
| L. infantum negative patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort. Receives: Other: Nanobiotechnology platforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests
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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start30 May 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiziana Lazzarotto, University of Bologna
- Investigators
- Tiziana Lazzarotto, PhD, Principal investigator, University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548841
- Sponsor's protocol ID
- ECLIPSE
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Burrow DT, Heggestad JT, Kinnamon DS, Chilkoti A. Engineering Innovative Interfaces for Point-of-Care Diagnostics. Curr Opin Colloid Interface Sci. 2023 Jun 8:101718. doi: 10.1016/j.cocis.2023.101718. Online ahead of print.
PubMed 37359425Okeke IN, Ihekweazu C. The importance of molecular diagnostics for infectious diseases in low-resource settings. Nat Rev Microbiol. 2021 Sep;19(9):547-548. doi: 10.1038/s41579-021-00598-5. Epub 2021 Jun 28.
PubMed 34183821Blann AD, Heitmar R. SARS-CoV-2 and COVID-19: A Narrative Review. Br J Biomed Sci. 2022 Sep 6;79:10426. doi: 10.3389/bjbs.2022.10426. eCollection 2022.
PubMed 36148046Perveen S, Negi A, Gopalakrishnan V, Panda S, Sharma V, Sharma R. COVID-19 diagnostics: Molecular biology to nanomaterials. Clin Chim Acta. 2023 Jan 1;538:139-156. doi: 10.1016/j.cca.2022.11.017. Epub 2022 Nov 18.
PubMed 36403665Rossolini GM, Mantengoli E. Treatment and control of severe infections caused by multiresistant Pseudomonas aeruginosa. Clin Microbiol Infect. 2005 Jul;11 Suppl 4:17-32. doi: 10.1111/j.1469-0691.2005.01161.x.
PubMed 15953020Breidenstein EB, de la Fuente-Nunez C, Hancock RE. Pseudomonas aeruginosa: all roads lead to resistance. Trends Microbiol. 2011 Aug;19(8):419-26. doi: 10.1016/j.tim.2011.04.005. Epub 2011 Jun 12.
PubMed 21664819Nicoletti G, Schito G, Fadda G, Boros S, Nicolosi D, Marchese A, Spanu T, Pantosti A, Monaco M, Rezza G, Cassone A, Garaci E; CIGAR (Gruppo Cooperativo Infezioni Gravi ed Antibiotico Resistenza). Bacterial isolates from severe infections and their antibiotic susceptibility patterns in Italy: a nationwide study in the hospital setting. J Chemother. 2006 Dec;18(6):589-602. doi: 10.1179/joc.2006.18.6.589.
PubMed 17267336Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, Murphy C, Dien Bard J, Naccache S, Ronen S, Hopp A, Mahmutoglu D, Faron ML, Ledeboer NA, Carroll A, Stone H, Akerele O, Everhart K, Bonwit A, Kwong C, Buckner R, Warren D, Fowler R, Chandrasekaran S, Huse H, Campeau S, Humphries R, Graue C, Huang A. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020 Jun 24;58(7):e00135-20. doi: 10.1128/JCM.00135-20. Print 2020 Jun 24.
PubMed 32350045Burza S, Croft SL, Boelaert M. Leishmaniasis. Lancet. 2018 Sep 15;392(10151):951-970. doi: 10.1016/S0140-6736(18)31204-2. Epub 2018 Aug 17.
PubMed 30126638Maroli M, Rossi L, Baldelli R, Capelli G, Ferroglio E, Genchi C, Gramiccia M, Mortarino M, Pietrobelli M, Gradoni L. The northward spread of leishmaniasis in Italy: evidence from retrospective and ongoing studies on the canine reservoir and phlebotomine vectors. Trop Med Int Health. 2008 Feb;13(2):256-64. doi: 10.1111/j.1365-3156.2007.01998.x.
PubMed 18304273Varani S, Cagarelli R, Melchionda F, Attard L, Salvadori C, Finarelli AC, Gentilomi GA, Tigani R, Rangoni R, Todeschini R, Scalone A, Di Muccio T, Gramiccia M, Gradoni L, Viale P, Landini MP. Ongoing outbreak of visceral leishmaniasis in Bologna Province, Italy, November 2012 to May 2013. Euro Surveill. 2013 Jul 18;18(29):20530.
PubMed 23929116Franceschini E, Puzzolante C, Menozzi M, Rossi L, Bedini A, Orlando G, Gennari W, Meacci M, Rugna G, Carra E, Codeluppi M, Mussini C. Clinical and Microbiological Characteristics of Visceral Leishmaniasis Outbreak in a Northern Italian Nonendemic Area: A Retrospective Observational Study. Biomed Res Int. 2016;2016:6481028. doi: 10.1155/2016/6481028. Epub 2016 Nov 23.
PubMed 27999807Todeschini R, Musti MA, Pandolfi P, Troncatti M, Baldini M, Resi D, Natalini S, Bergamini F, Galletti G, Santi A, Rossi A, Rugna G, Granozzi B, Attard L, Gaspari V, Liguori G, Ortalli M, Varani S. Re-emergence of human leishmaniasis in northern Italy, 2004 to 2022: a retrospective analysis. Euro Surveill. 2024 Jan;29(4):2300190. doi: 10.2807/1560-7917.ES.2024.29.4.2300190.
PubMed 38275016Boelaert M, Verdonck K, Menten J, Sunyoto T, van Griensven J, Chappuis F, Rijal S. Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease. Cochrane Database Syst Rev. 2014 Jun 20;2014(6):CD009135. doi: 10.1002/14651858.CD009135.pub2.
PubMed 24947503Tateo F, Fiorino S, Peruzzo L, Zippi M, De Biase D, Lari F, Melucci D. Effects of environmental parameters and their interactions on the spreading of SARS-CoV-2 in North Italy under different social restrictions. A new approach based on multivariate analysis. Environ Res. 2022 Jul;210:112921. doi: 10.1016/j.envres.2022.112921. Epub 2022 Feb 10.
PubMed 35150709