Overview

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

Status:
Not yet recruiting
Trial end date:
2022-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
George Washington University
Collaborators:
Allied Research Society
Hospital Infantil de Niño Jesús de Barranquilla (HINJ)
Naval Medical Research Center
Universidad Bosque
Treatments:
Zanamivir
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 documented fever >38C in the last 24 hours.

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).

Exclusion Criteria:

1. Pregnancy or lactation

2. Children in Care of the state

3. Patients who are unlikely to survive 48 hours

4. Elevated alanine aminotransferase ≥3 times the upper limit of normal (ULN)

5. Total bilirubin ≥2 × ULN

6. Unstable cardiac disease or arrhythmia at baseline

7. History of significant cardiac disease

8. Treatment with another investigational drug or other intervention within 1 month.