Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV2 positive patients | Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort. |
| |
| SARS-CoV2 negative patients | Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort. |
| |
| P. aeruginosa positive patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort. |
| |
| P. aeruginosa negative patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort. |
| |
| L. infantum positive patients | Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort. |
| |
| L. infantum negative patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanobiotechnology platforms | Other | The analyses will be carried out using the novel devices, which are of two types:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tiziana Lazzarotto, PhD | University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical and Surgical Sciences, University of Bologna | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37359425 | Background | 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. | |
| 34183821 | Background | 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. |
| Label | URL |
|---|---|
| Antimicrobial resistance surveillance in Europe 2023 - 2021 data | View source |
Not provided
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.
Summary data will be published starting 6 months after the end of the study.
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2024 | Aug 7, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| D010272 | Parasitic Diseases |
| D000086382 | COVID-19 |
| D011552 | Pseudomonas Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort. |
|
|
| 36148046 | Background | 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. |
| 36403665 | Background | 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. |
| 15953020 | Background | 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. |
| 21664819 | Background | 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. |
| 17267336 | Background | 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. |
| 32350045 | Background | 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. |
| 30126638 | Background | 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. |
| 18304273 | Background | 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. |
| 23929116 | Background | 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. |
| 27999807 | Background | 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. |
| 38275016 | Background | 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. |
| 24947503 | Background | 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. |
| 35150709 | Background | 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. |
| WHO Regional office for Europe. Manual on case management and surveillance of the leishmaniases in the WHO European Region | View source |
| Wehrens R. Chemometrics with R: Multivariate Data Analysis in the Natural Sciences and Life Sciences | View source |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |