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

Launched by GEORGE WASHINGTON UNIVERSITY · Oct 15, 2020

Keywords

ClinConnect Summary

The ZAP-DENGUE trial is studying a medication called zanamivir to see if it can help treat a serious problem called vascular permeability syndrome in patients with dengue fever. This condition can lead to severe complications and is a major cause of death from dengue. The trial is looking for participants who are at least 8 years old, have been diagnosed with dengue fever, and have had a fever above 38 degrees Celsius in the last 24 hours. They should also be experiencing warning signs of severe dengue, such as abdominal pain or bleeding.

If you or someone you know is interested in participating, you’ll need to provide consent and be willing to follow the study's procedures for five days of treatment. Participants will receive either the study medication or a placebo (a look-alike treatment with no active ingredients) through an intravenous line, meaning it will be given directly into the bloodstream. The trial is currently recruiting participants and aims to ensure everyone’s safety throughout the process.

Gender

ALL

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. Enrollment in EPS (Entidadas Promotoras de Salud) or Sistema General de Seguridad Social en Salud (SGSSS)- Colombian Public Health Insurance.
• Exclusion Criteria:
• • 1. Pregnancy or lactation
• • 2. Children in Care of the state
• • 3. Patients who are unlikely to survive 48 hours
• • 4. Unstable cardiac disease or arrhythmia at baseline
• • 5. History of significant cardiac disease
• • 6. Treatment with another investigational drug or other intervention within 1 month.
• • 7. Encephalitis or unable to consent