Zanamivir treatment for severe dengue symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation assessing the safety and efficacy of intravenous zanamivir over five days for treating vascular permeability syndrome in patients with dengue fever. The study aims to determine if zanamivir can safely reduce serum sialic acid levels and decrease the incidence of moderate to severe plasma leakage, a major cause of mortality in dengue. Participants aged 7 years and older diagnosed with dengue fever will be randomized to receive either zanamivir or a placebo, with careful monitoring of their clinical status and laboratory parameters throughout the treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinica de la Costa SAS
  Barranquilla, Colombia, Colombia Recruiting
• Cien Salud IPS SAS
  Barranquilla, Atlántico, Colombia Active not recruiting

Study contacts

• Principal investigator: Aileen Chang, MD — George Washington University
• Study coordinator: Aileen Y Chang, MD
• Email: chang@email.gwu.edu
• Phone: 202-741-6562

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.