Clinical trial NCT06782607: Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients with Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia with High Risk of Multidrug Resistant Pathogen
Official title: Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients with Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia with High Risk of Multidrug Resistant Pathogen
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infectious Disease of Lung
Molecular Diagnosis
Pneumonia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.

The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.

To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

* Patients who have received complete information about the research and who have not objected to the use of its data
* Patients with suspected pneumonia infection

Exclusion Criteria: Patients with following conditions;

* Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
* Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
* Cardiogenic shock
* Life-threatening gastrointestinal hemorrhage
* Drug overdose
* Advanced-stage cancer with predicted survival less than 1 year

Primary outcomes:
measure: Therapeutic decision [Time Frame: 24 hours following the FilmArray results]
timeFrame: 24 hours following the FilmArray results
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
References:
citation: Stafylaki D, Maraki S, Vaporidi K, Georgopoulos D, Kontoyiannis DP, Kofteridis DP, Chamilos G. Impact of Molecular Syndromic Diagnosis of Severe Pneumonia in the Management of Critically Ill Patients. Microbiol Spectr. 2022 Oct 26;10(5):e0161622. doi: 10.1128/spectrum.01616-22. Epub 2022 Sep 26.
citation: High J, Enne VI, Barber JA, Brealey D, Turner DA, Horne R, Peters M, Dhesi Z, Wagner AP, Pandolfo AM, Stirling S, Russell C, O'Grady J, Swart AM, Gant V, Livermore DM; INHALE Study Group. INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 7;22(1):680. doi: 10.1186/s13063-021-05618-6.
citation: Kosai K, Akamatsu N, Ota K, Mitsumoto-Kaseida F, Sakamoto K, Hasegawa H, Izumikawa K, Mukae H, Yanagihara K. BioFire FilmArray Pneumonia Panel enhances detection of pathogens and antimicrobial resistance in lower respiratory tract specimens. Ann Clin Microbiol Antimicrob. 2022 Jun 4;21(1):24. doi: 10.1186/s12941-022-00512-8.