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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759494
• Other study ID #: MD-37-2022
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: RAED EMAD ALY, MASTER
• Phone: 00201111871351
• Email: raedemad89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View 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. — View Citation

Poritz MA, Blaschke AJ, Byington CL, Meyers 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: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical	Clinical resolution of sepsis ( by percentage)	through study completion, an average of 1 year
Primary	Pharmacoeconomic	1-Reduction of cost and reduction of respective antimicrobial cases (by percentage )	through study completion, an average of 1 year
Primary	clinical	survival (by percentage )	through study completion, an average of 1 year
Primary	clinical	length of stay in ICU (by days)	through study completion, an average of 1 year
Primary	clinical	change strategy of antibiotic in first week (by percentage)	through study completion, an average of 1 year
Primary	pharmacoeconomic	DOT of antimicrobial (by days )	through study completion, an average of 1 year

External Links

•   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
•   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.
•   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