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Recruiting Phase 2 NCT04597437

Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)

Trial Parameters

Condition Dengue Fever
Sponsor George Washington University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 74
Sex ALL
Min Age 7 Years
Max Age N/A
Start Date 2024-03-15
Completion 2026-09-30
Interventions
ZanamivirPlacebo

Brief Summary

ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever.

Eligibility Criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged \>7 years 4. Willingness to receive intravenous medication and be willing to adhere to the medication regimen 5. Have a diagnosis of dengue by dengue NS1 rapid test 6. Have had a self-informed fever \>38 degrees C in the last 3 days. 7. Have dengue with warning signs as per the 2009 WHO criteria including one of the following: abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy, restlessness, liver enlargement over 2 cm, augmented hematocrit, thrombocytopenia or severe dengue defined as dengue with severe plasma leakage leading to dengue shock and/or fluid accumulation with respiratory distress; severe hemorrhage; severe organ impairment (hepatic damage, renal impairment, cardiomyopathy, encephalopathy or encephalitis). 8. Enroll

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