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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pneumonia Panel by FilmArray.
- Who it may be relevant to
- Registry conditions: Infectious Disease of Lung, Molecular Diagnosis, Pneumonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Diagnostic test Pneumonia Panel by FilmArray
The Pneumonia Panel comprehensively identifies 33 potential pathogen targets from sputum-like (including endotracheal aspirate) and bronchoalveolar lavage (BAL)-like (including mini-BAL) samples. For 15 of the bacteria, the Pneumonia Panel provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen.
Primary outcome measures
- Therapeutic decision [Time Frame: 24 hours following the FilmArray results] [Time frame: 24 hours following the FilmArray results]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Siriraj Hospital, Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok
Publications
- 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. PMID 36154180
- 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 pr PMID 34620213
- 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. PMID 35659683
Identifiers
NCT: NCT06782607 · 010/2025