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: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05759494
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 9.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Diagnostic Test: rapid diagnostic test (multiplex PCR filmArray)

Detailed Description

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)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
A 50 patients before use rapid diagnostic test (multiplex PCR filmArray)
B 50 patients after use rapid diagnostic test (multiplex PCR filmArray)	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

1. clinical [through study completion, an average of 1 year]

   Clinical resolution of sepsis ( by percentage)

2. Pharmacoeconomic [through study completion, an average of 1 year]

   1-Reduction of cost and reduction of respective antimicrobial cases (by percentage )

3. clinical [through study completion, an average of 1 year]

   survival (by percentage )

4. clinical [through study completion, an average of 1 year]

   length of stay in ICU (by days)

5. clinical [through study completion, an average of 1 year]

   change strategy of antibiotic in first week (by percentage)

6. pharmacoeconomic [through study completion, an average of 1 year]

   DOT of antimicrobial (by days )

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 18 and 85 years

• Critically ill patients admitted to ICU, diagnosed as sepsis.

Exclusion Criteria:

• Surviving time less than 48 hours.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

• 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.
• 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.

• Responsible Party: Mohamed Fakher, assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05759494
• Other Study ID Numbers: MD-37-2022
• First Posted: Mar 8, 2023
• Last Update Posted: Mar 8, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Mar 8, 2023