Using Montelukast to Prevent Liver Issues in Adult Dengue Patients
Official title: Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients: a Randomized, Double-blind, Placebo Controlled, Superiority Trial
Run by Phramongkutklao College of Medicine and Hospital · NCT06747130 · Data updated 2026-11-12
This study is testing if the medication montelukast can help prevent liver problems in adults with dengue fever.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Phramongkutklao College of Medicine and Hospital Academic / other |
| Locations | 1 site (Bangkok) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT06747130 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who have been diagnosed with dengue and are admitted to the hospital.
✕Probably not a fit
Patients with other causes of fever, critically ill patients requiring intensive care, or those with a history of liver disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the efficacy of montelukast, a leukotriene receptor antagonist, in preventing liver enzyme elevations in adults diagnosed with dengue fever. The study aims to determine whether montelukast can reduce the incidence of transaminase elevations, which are associated with severe dengue complications. Participants will be monitored for safety and any medical issues arising from the medication. The trial includes both Phase 2 and Phase 3 evaluations to assess the drug's effectiveness and safety profile.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce liver complications in adult dengue patients, improving their overall health outcomes.
How similar studies have gone: While the approach of using montelukast in dengue patients is novel, previous studies have shown that leukotriene blockade can reduce plasma leakage in animal models, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age \>18 years * Dengue infection diagnosed by NS1 antigen, or polymerase chain reaction * Admitted to the hospital * Written informed consent from patient or attending relative able to and willing to give informed consent Exclusion Criteria: * Other possible cause of fever other than dengue infection * Pregnancy * Unable to take medication * Aminotransferase level above 150 U/l * Allergy to paracetamol or tramadol * Paracetamol indicated for condition other than dengue infection * Critically ill patient who need ICU or invasive ventilation support * History of cirrhosis * Unable to communicate * Other indication of montelukast * History of psychiatric illness
Where it's running
-
Phramongkutklao Hospital
Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Vasin Vasikasin, MD PhD
- Email: vvasin@gmail.com
- Phone: 66+027639300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.