A Phase 2/3 interventional study of Montelukast and Montelukast Placebo in Dengue, Montelukast and Transaminases, sponsored by Phramongkutklao College of Medicine and Hospital. Recruiting at 1 site in Thailand. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Phramongkutklao College of Medicine and Hospital · Phase 2/3, Interventional, and Treatment
The goal of this clinical trial is to learn if drug montelukast works to treat dengue in adults. It will also learn about the safety of drug montelukast . The main questions it aims to answer are:
Does drug montelukast lower the incidence of liver enzyme elevations in participants ? What medical problems do participants have when taking drug montelukast ?
Dengue remains a significant and growing public health issue in many tropical countries, with almost 4 billion people estimated to be at risk worldwide and an annual incidence of approximately 400 million infections. In 2019 alone, 5.2 million cases of dengue were reported globally.
In addition to its acute clinical manifestations, dengue is a leading cause of liver failure in tropical regions. Elevated concentrations of transaminases have been strongly correlated with disease severity. Severe acute hepatitis in dengue patients is associated with prolonged hospital stays, increased mortality, bleeding complications, and renal failure. While transaminase elevations are commonly linked to shock and subsequent ischemic hepatitis, studies indicate that these elevations often precede the onset of shock by several days. Notably, elevated transaminase levels during the febrile stage have been predictive of subsequent shock, underscoring their potential role as an early marker of disease progression.
Leukotrienes play a pivotal role in the pathophysiology of dengue by promoting plasma leakage and leukocyte adhesion within postcapillary venules. In dengue patients, leukotriene levels are markedly elevated-up to 35-38 times baseline levels-during the febrile and defervescence stages, returning to normal during the convalescent phase. Animal model studies have demonstrated that leukotriene blockade significantly reduces plasma leakage, suggesting its potential as a therapeutic target.
Currently, the management of dengue is limited to symptomatic treatment and intravenous fluid replacement, with no specific interventions proven to prevent complications. Preclinical studies have identified nafamostat, a tryptase inhibitor, and montelukast, a leukotriene receptor antagonist, as promising agents for reducing plasma leakage. An open-label clinical study in 2018 reported a 22% absolute risk reduction in dengue shock syndrome among patients treated with montelukast compared to standard care. However, a subsequent randomized controlled trial in 2024 failed to demonstrate efficacy of montelukast in preventing plasma leakage or warning signs of severe dengue. This discrepancy may reflect either the ineffectiveness of montelukast or the low incidence of warning signs in the trial population. Interestingly, secondary analyses revealed that participants in the montelukast group had a lower incidence of transaminase elevations compared to those receiving placebo, suggesting a potential hepatoprotective effect.
This study aims to evaluate the efficacy of montelukast in reducing the incidence of transaminase elevations in adult patients with dengue.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 82 is below the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Phramongkutklao College of Medicine and Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
Drug: Montelukast
a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
Drug: Montelukast Placebo
A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
Serum transaminase levels on the recovery day
Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared. The recovery day is defined as the day the participant was discharged from the hospital.
Time frame: From enrollment to the end of treatment at 10 days
Proportion of subjects with abnormal serum transaminase levels on the recovery day
Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared.
Time frame: From enrollment to the end of treatment at 10 days
Length of stay
Duration from hospital admission to discharge will be compared.
Time frame: From enrollment to the end of treatment at 10 days
Changes in serum transaminase levels
The change in serum transaminase levels from baseline at admission will be compared.
Time frame: From enrollment to the end of treatment at 10 days
Rate of dengue with warning signs
Rate of a composite outcome including abdominal tenderness or pain, persistent vomiting, clinical fluid accumulation, mucosal bleeding, liver enlargement \>2cm, increase in hematocrit concurrent with decrease in platelet count
Time frame: From enrollment to the end of treatment at 10 days
Rate of severe dengue
Rate of a composite outcome including shock, fluid accumulation with respiratory distress, severe bleeding leading to hypotension or decreased hematocrit, liver transaminase \>1000, impaired consciousness, heart and other organ failure
Time frame: From enrollment to the end of treatment at 10 days
Rate of dengue shock
Rate of hypotension or the pulse pressure of ≤ 20 mm Hg
Time frame: From enrollment to the end of treatment at 10 days
Hematocrit and platelet
Hematocrit and platelet levels will be compared.
Time frame: From enrollment to the end of treatment at 10 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jan 2027, 24 months after the start.
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Studies of the drug tested here: Montelukast
Phramongkutklao College of Medicine and Hospital