The Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Test (Multiplex PCR FilmArray) on Antimicrobial Decision Making Compared to Conventional Decision Making Among Critically Ill Patients
NCT ID: NCT05759494
Last Updated: 2023-03-08
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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UNKNOWN
100 participants
OBSERVATIONAL
2023-05-01
2024-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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A
50 patients before use rapid diagnostic test (multiplex PCR filmArray)
No interventions assigned to this group
B
50 patients after use rapid diagnostic test (multiplex PCR filmArray)
rapid diagnostic test (multiplex PCR filmArray)
novel diagnostic platform, the "FilmArray®", which combines automated sample preparation, nucleic acid extraction and PCR-based detection of 31 separate targets from a single unprocessed sample in one hour. It combines nesting and multiplexing of the PCR (referred to here as nested multiplex or "nmPCR") together with DNA melting curve analysis.
Interventions
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rapid diagnostic test (multiplex PCR filmArray)
novel diagnostic platform, the "FilmArray®", which combines automated sample preparation, nucleic acid extraction and PCR-based detection of 31 separate targets from a single unprocessed sample in one hour. It combines nesting and multiplexing of the PCR (referred to here as nested multiplex or "nmPCR") together with DNA melting curve analysis.
Eligibility Criteria
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Inclusion Criteria
* Critically ill patients admitted to ICU, diagnosed as sepsis.
Exclusion Criteria
16 Years
85 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Fakher
assistant professor
Central Contacts
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References
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Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
Peeters P, Ryan K, Karve S, Potter D, Baelen E, Rojas-Farreras S, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: real-world insights in patients with complicated, health care-associated intra-abdominal infection. Infect Drug Resist. 2019 Jan 31;12:329-343. doi: 10.2147/IDR.S184116. eCollection 2019.
Poritz MA, Blaschke AJ, Byington CL, Allen L, Nilsson K, Jones DE, Thatcher SA, Robbins T, Lingenfelter B, Amiott E, Herbener A, Daly J, Dobrowolski SF, Teng DH, Ririe KM. FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection. PLoS One. 2011;6(10):e26047. doi: 10.1371/journal.pone.0026047. Epub 2011 Oct 19.
Related Links
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Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiol
he antibiotic use and resistance can contribute to the rates of sepsis hospitalization and mortality
However, approximately 20-30% of initial antibiotic treatment was reported to be ineffective in patients. Thus, further delay of effective antibiotic treatment could increase the risk of mortality
Here we use a novel diagnostic platform, the "FilmArray®", which combines automated sample preparation, nucleic acid extraction and PCR-based detection of 31 separate targets from a single unprocessed sample in one hour.
Other Identifiers
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MD-37-2022
Identifier Type: -
Identifier Source: org_study_id
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