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

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT05759494

Acronym / sponsor ID

MD-37-2022

Conditions

Sepsis

Study type

Observational

Recruitment status

Unknown status

Enrolment

100 participants (estimated)

Lead sponsor

Cairo UniversityUniversity, hospital or other

Study start

1 May 2023 (estimated)

Primary completion

1 Jan 2024 (estimated)

Study completion

1 Feb 2024 (estimated)

First posted

8 Mar 2023 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Cross-sectional

Number of arms

2

Who may qualify

Ages

16 to 85 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. clinical

   Time frame: through study completion, an average of 1 year

   Clinical resolution of sepsis ( by percentage)

2. Pharmacoeconomic

   Time frame: through study completion, an average of 1 year

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

3. clinical

   Time frame: through study completion, an average of 1 year

   survival (by percentage )

4. clinical

   Time frame: through study completion, an average of 1 year

   length of stay in ICU (by days)

5. clinical

   Time frame: through study completion, an average of 1 year

   change strategy of antibiotic in first week (by percentage)

6. pharmacoeconomic

   Time frame: through study completion, an average of 1 year

   DOT of antimicrobial (by days )

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
• Background: PubMed 26903338Singer 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.
• Background: PubMed 29675566Levy 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.
• Results publication: PubMed 30774399Peeters 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.
• Results publication: PubMed 22039434Poritz 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.
• 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 epidemiolLink provided by the sponsor.
• he antibiotic use and resistance can contribute to the rates of sepsis hospitalization and mortalityLink provided by the sponsor.
• 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 mortalityLink provided by the sponsor.
• 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.Link provided by the sponsor.
• Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.