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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

M

Mahidol University

Status

Not yet enrolling

Conditions

Infectious Disease of Lung
Molecular Diagnosis
Pneumonia

Treatments

Diagnostic Test: Pneumonia Panel by FilmArray

Study type

Interventional

Funder types

Other

Identifiers

NCT06782607
010/2025

Details and patient eligibility

About

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.

Full description

Not provided

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Experimental: Pneumonia panel group
Experimental group
Description:
Pneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel
Treatment:
Diagnostic Test: Pneumonia Panel by FilmArray
No Intervention: Standard of care
No Intervention group
Description:
Standard practice

Trial contacts and locations

1

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Central trial contact

Adhiratha Boonyasiri, MD, MSc, PhD

Data sourced from clinicaltrials.gov

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