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

NCT06744777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Severe Dengue

Interventions

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.

Sponsors & Collaborators

  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Said Amin, MBBS,FCPS · Department of Medicine Hayatabad Medical Complex Peshawar

  • Sheraz Fazid, MBBS,MPH · Institute of Public Health and Social Science, Khyber Medical University Peshawar

  • Noman Arif, MBBS · Institute of Public Health and Social Science, Khyber Medical University Peshawar

  • Akhtar Sherin, MBBS,MHR,PHD · Kohat Institute of Medical Science Peshawar Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-04-28
Completion
2025-05-29

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744777 on ClinicalTrials.gov