Dengue Clinical Trial
Official title:
Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients: a Multicenter Randomized, Double-blind, Placebo Controlled, Superiority Trial
Verified date | July 2023 |
Source | Phramongkutklao College of Medicine and Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the efficacy of montelukast in reducing the incidence of dengue warning signs in adult dengue patients.
Status | Completed |
Enrollment | 358 |
Est. completion date | June 17, 2023 |
Est. primary completion date | June 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - at least 18 years old - diagnosis of dengue - positive NS1 antigen or polymerase chain reaction (PCR) test Exclusion Criteria: - any warning sign of dengue - concurrent diagnosis of other causes of fever, such as malaria or heat stroke - pregnancy - being unable to take medication by mouth - critical illness needing intubation or admission to an intensive care unit - being unable to communicate - other indication of montelukast |
Country | Name | City | State |
---|---|---|---|
Thailand | Phramongkutklao Hospital | Bangkok | |
Thailand | Hatyai Hospital | Hat Yai | Songkhla |
Thailand | Ananda Mahidol Hospital | Lopburi | |
Thailand | Fort Suranari Hospital | Nakhon Ratchasima |
Lead Sponsor | Collaborator |
---|---|
Phramongkutklao College of Medicine and Hospital |
Thailand,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 However, lethargy will be excluded as a criterion for warning sign as almost all patients reported subjective lethargy. |
14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter. | |
Secondary | Rate of each component of composite outcome of dengue with warning signs | Rate of each component of composite outcome of dengue with warning signs
abdominal tenderness or pain persistent vomiting clinical fluid accumulation mucosal bleeding liver enlargement >2cm increase in hematocrit concurrent with decrease in platelet count |
14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter | |
Secondary | Rate of hospitalization | Rate of admission to hospital | 14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter | |
Secondary | Length of hospital stay | Length of hospital stay | up to 90 days | |
Secondary | 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 |
14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter | |
Secondary | Rate of dengue shock | Rate of hypotension or the pulse pressure of = 20 mm Hg | 14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter | |
Secondary | 30-day mortality | death with in 30 days | 30 days |
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