Development and Validation of (Bio)Sensors for the Identification of Pathogens
NCT ID: NCT06548841
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
149 participants
OBSERVATIONAL
2024-05-30
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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SARS-CoV2 positive patients
Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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Tiziana Lazzarotto
Director of the Microbiology Unit - IRCCS Azienda Ospedaliero-Universitaria di Bologna
Principal Investigators
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Tiziana Lazzarotto, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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Department of Medical and Surgical Sciences, University of Bologna
Bologna, Bologna, Italy
Countries
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References
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Todeschini 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.
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.
Okeke 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.
Blann 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.
Perveen 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.
Rossolini 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.
Breidenstein 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.
Nicoletti 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.
Buchan 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.
Burza 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.
Maroli 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.
Varani 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.
Franceschini 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.
Boelaert 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.
Tateo 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.
Provided Documents
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Document Type: Study Protocol
Related Links
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Antimicrobial resistance surveillance in Europe 2023 - 2021 data
WHO Regional office for Europe. Manual on case management and surveillance of the leishmaniases in the WHO European Region
Wehrens R. Chemometrics with R: Multivariate Data Analysis in the Natural Sciences and Life Sciences
Other Identifiers
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ECLIPSE
Identifier Type: -
Identifier Source: org_study_id
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