Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorPhramongkutklao College of Medicine and Hospital
About this trial
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 ?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other possible cause of fever other than dengue infection
Pregnancy
Unable to take medication
Aminotransferase level above 150 U/l
Trial design
Design model
Parallel
Treatments tested in this trial
Montelukast
DrugA 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
Montelukast Placebo
DrugA 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
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: MontelukastExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
Length of stay
Duration from hospital admission to discharge will be compared.
Time frame
From enrollment to the end of treatment at 10 days3
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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov