Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating intravenous zanamivir treatment to address vascular permeability syndrome, a leading cause of death in dengue fever. This pilot randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of a five-day zanamivir course in patients aged 7 years and older diagnosed with dengue fever featuring warning signs or severe dengue according to WHO 2009 criteria. The study focuses on whether zanamivir can reduce serum sialic acid levels and decrease the incidence of moderate or severe plasma leakage. Participants are randomly assigned to receive either intravenous zanamivir or a placebo. Those in the treatment group weighing less than 50 kg will receive 12 mg/kg, while those 50 kg or more will receive 600 mg every twelve hours for five days, with dosing adjusted for kidney function. The placebo group receives normal saline intravenously on the same schedule. Both groups undergo daily clinical evaluations and blood tests during treatment. Throughout the five-day medication period and at a 14-day follow-up, participants will have blood drawn to measure hematocrit, kidney function, and other biological markers. Researchers will monitor signs of vascular permeability through clinical assessments and imaging such as ultrasound or radiographs. Safety is tracked by recording any adverse events. The primary outcome is the incidence of treatment-related adverse events over 14 days, with secondary outcomes including biomarker levels and preliminary clinical efficacy.

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