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New treatment option for Dengue Fever
Official title Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)
ClinicalTrials.gov ID: NCT04597437
What this study is testing
What is Zanamivir?
Zanamivir is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for dengue fever.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 and older
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged \>7 years
- Willingness to receive intravenous medication and be willing to adhere to the medication regimen
- Have a diagnosis of dengue by dengue NS1 rapid test
You likely can't join if
- Pregnancy or lactation
- Children in Care of the state
- Patients who are unlikely to survive 48 hours
- Unstable cardiac disease or arrhythmia at baseline
- History of significant cardiac disease
- Treatment with another investigational drug or other intervention within 1 month.
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged \>7 years
- Willingness to receive intravenous medication and be willing to adhere to the medication regimen
- Have a diagnosis of dengue by dengue NS1 rapid test
- Have had a self-informed fever \>38 degrees C in the last 3 days.
- 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...
- Enrollment in EPS (Entidadas Promotoras de Salud) or Sistema General de Seguridad Social en Salud (SGSSS)- Colombian Public Health Insurance.
- Pregnancy or lactation
- Children in Care of the state
- Patients who are unlikely to survive 48 hours
- Unstable cardiac disease or arrhythmia at baseline
- History of significant cardiac disease
- Treatment with another investigational drug or other intervention within 1 month.
- Encephalitis or unable to consent
The study team makes the final eligibility decision.
Where it's taking place
- Barranquilla, Atlántico, Colombia
- Barranquilla, Colombia, Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barranquilla, Atlántico, Colombia; Barranquilla, Colombia, Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.