NCT06744777

The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever

The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever: A Double-blind, Randomized Control Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Khyber Medical University Peshawar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the comparative efficacy of standard treatment plus Ribavirin versus standard treatment alone in preventing clinically significant hemorrhage among patients diagnosed with dengue fever. It is a double-blind, randomized control trial aimed at determining whether the addition of Ribavirin improves clinical outcomes, particularly reducing bleeding events.

Detailed description

Dengue fever, a significant public health concern, presents varying severity from asymptomatic to life-threatening complications such as hemorrhage or shock. This study evaluates the effectiveness of Ribavirin when combined with standard treatment in mitigating severe bleeding complications in dengue patients. Conducted at multiple public sector hospitals in Khyber Pakhtunkhwa, the trial employs a rigorous methodology, including block randomization, double-blinding, and predefined eligibility criteria. Outcomes include changes in bleeding grades, platelet counts, acute-phase reactants, and hospital stay length. The findings aim to inform policy decisions and enhance dengue fever management protocols.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Severe Dengue

Interventions

Type	Name	Description
DRUG	Ribavirin	Ribavirin is an antiviral medication administered as part of the intervention arm. It will be provided orally in a dosage of 15 mg/kg body weight twice daily (BD) for a duration of 7 days. The drug has demonstrated efficacy in vitro and in vivo against RNA viruses, including dengue, through mechanisms such as inosine monophosphate inhibition and immunomodulation.
OTHER	Standard Treatment	The standard treatment for dengue fever includes supportive care measures aimed at managing symptoms and preventing complications. These measures typically involve: Intravenous (IV) fluid therapy for rehydration and maintaining hemodynamic stability. Platelet transfusion as needed, based on clinical assessment and platelet counts. Antipyretics for fever management (excluding non-steroidal anti-inflammatory drugs to prevent bleeding risks). Continuous monitoring of vital signs and blood parameters, including platelet counts and hematocrit levels. No antiviral drugs or additional pharmacological interventions are included in the standard treatment protocol.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-04-28
• Completion: 2025-05-29
• First posted: 2024-12-20
• Last updated: 2025-06-26

Locations

4 sites across 1 country: Pakistan