Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597437
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2020-10-09
Brief Title:
Zanamivir Treatment of Vascular Permeability in Dengue ZAP-DENGUE
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Zanamivir Treatment of Vascular Permeability in Dengue ZAP-DENGUE A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZAP-DENGUE
Brief 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
Detailed Description:
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 Our central hypothesis is that zanamivir treatment is safe in patients with dengue infection will significantly decrease serum sialic acid levels and will result in fewer patients with the development of moderate or severe clinical plasma leakage 74 male and non-pregnant female volunteers age 7 years and older from Colombia with a diagnosis of dengue fever with warning signs or severe dengue as per the World Health Organization 2009 definition with the presence of fever and positive rapid test for the presence of dengue non-structural protein-1 NS1 will be randomized to zanamivir versus placebo In the treatment group all participants weighing less than 50 kg will receive 12 mgkg and all participants weighing 50 kg and above will receive 600 mg as the initial dose intravenously every twelve hours for 5 days adjusted for renal function In the placebo group participants will receive placebo normal saline solution intravenously every twelve hours for 5 days
All patients will receive blood draws for assessment of hematocrit renal function and biologic efficacy endpoints and clinical evaluation of signs and symptoms of vascular permeability which may include ultrasound and radiograph and adverse events daily during the five days of medication administration and once at follow up at 14 days
All patients will receive blood draws for assessment of hematocrit renal function and biologic efficacy endpoints and clinical evaluation of signs and symptoms of vascular permeability which may include ultrasound and radiograph and adverse events daily during the five days of medication administration and once at follow up at 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None