Идёт набор NCT06747130

Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients

Фаза II / Фаза III С лечением Dengue Montelukast Transaminases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Montelukast, Montelukast Placebo.
Кому может быть актуально: Состояния в реестре: Dengue, Montelukast, Transaminases. Базовые параметры: от 20 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Таиланд
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients: a Randomized, Double-blind, Placebo Controlled, Superiority Trial

Обзор

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 ?

Подробное описание

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.

Вмешательства

Препарат 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
Препарат 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

Первичные конечные точки

Serum transaminase levels on the recovery day [Срок оценки: From enrollment to the end of treatment at 10 days]

Вторичные конечные точки (7)

Proportion of subjects with abnormal serum transaminase levels on the recovery day [Срок оценки: From enrollment to the end of treatment at 10 days]
Length of stay [Срок оценки: From enrollment to the end of treatment at 10 days]
Changes in serum transaminase levels [Срок оценки: From enrollment to the end of treatment at 10 days]
Rate of dengue with warning signs [Срок оценки: From enrollment to the end of treatment at 10 days]
Rate of severe dengue [Срок оценки: From enrollment to the end of treatment at 10 days]
Rate of dengue shock [Срок оценки: From enrollment to the end of treatment at 10 days]
Hematocrit and platelet [Срок оценки: From enrollment to the end of treatment at 10 days]

Критерии участия

Критерии включения

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