Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05759494
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092025', 'term': 'Rapid Diagnostic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000067716', 'term': 'Point-of-Care Testing'}, {'id': 'D019095', 'term': 'Point-of-Care Systems'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Clinical resolution of sepsis ( by percentage)'}, {'measure': 'Pharmacoeconomic', 'timeFrame': 'through study completion, an average of 1 year', 'description': '1-Reduction of cost and reduction of respective antimicrobial cases (by percentage )'}, {'measure': 'clinical', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'survival (by percentage )'}, {'measure': 'clinical', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'length of stay in ICU (by days)'}, {'measure': 'clinical', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'change strategy of antibiotic in first week (by percentage)'}, {'measure': 'pharmacoeconomic', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'DOT of antimicrobial (by days )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '26903338', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29675566', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30774399', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22039434', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/26903338/', 'label': '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'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29675566/', 'label': 'he antibiotic use and resistance can contribute to the rates of sepsis hospitalization and mortality'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6362915/', 'label': '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'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/22039434/', 'label': '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.'}]}, 'descriptionModule': {'briefSummary': 'We will show in this study the impact of use the rapid diagnostic method (multiplex PCR filmArray) on clinical and pharmacoeconomic aspects among Critically Ill Patients.', 'detailedDescription': 'Prospective and retrospective study on 100 patients complaining from sepsis in intensive care unit in International Medical center. Two phase study 50 patients before and 50 patients after use rapid diagnostic test (multiplex PCR filmArray)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 male and female patients, age between 16 and 85. One-year study 6 months before and 6 months after using the rapid diagnostic test.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 85 years\n* Critically ill patients admitted to ICU, diagnosed as sepsis.\n\nExclusion Criteria:\n\n* Surviving time less than 48 hours.'}, 'identificationModule': {'nctId': 'NCT05759494', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MD-37-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': '50 patients before use rapid diagnostic test (multiplex PCR filmArray)'}, {'label': 'B', 'description': '50 patients after use rapid diagnostic test (multiplex PCR filmArray)', 'interventionNames': ['Diagnostic Test: rapid diagnostic test (multiplex PCR filmArray)']}], 'interventions': [{'name': 'rapid diagnostic test (multiplex PCR filmArray)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'RAED EMAD ALY, MASTER', 'role': 'CONTACT', 'email': 'raedemad89@gmail.com', 'phone': '00201111871351'}, {'name': 'mohamed amin fakher, M.D', 'role': 'CONTACT', 'email': 'mohamed.fakher@kasralainy.ed.eg', 'phone': '00201062275876'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Mohamed Fakher', 'investigatorAffiliation': 'Cairo University'}}}}