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

Last updated: December 17, 2024
Sponsor: Khyber Medical University Peshawar
Overall Status: Active - Recruiting

Phase

3

Condition

Fever

Hemorrhage

Treatment

Standard Treatment

Ribavirin

Clinical Study ID

NCT06744777
KMU/DIR/CTU/2024/012
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients aged 18 years and above.

  • Hospitalized patients diagnosed with dengue fever, confirmed via:

  • Positive Dengue NS1 antigen test

  • Dengue IgM antibodies

  • Dengue RNA PCR.

  • Patients presenting with various severities of illness, as classified by the WHOdengue severity classification.

Exclusion

Exclusion Criteria:

  • Patients taking antiplatelet or anticoagulant medications.

  • Patients with known bleeding disorders (e.g., hemophilia, von Willebrand disease,end-stage renal disease, or liver cirrhosis).

  • Patients with HIV undergoing antiviral therapy.

  • Pregnant women.

  • Patients with hypersensitivity to Ribavirin.

  • Patients with WHO Grade 1 bleeding (few petechiae without clinical significance).

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: Standard Treatment
Phase: 3
Study Start date:
December 17, 2024
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Kohat Institute of Medical Science

    Kohat, KPK
    Pakistan

    Active - Recruiting

  • Gandhara Medical Hospital

    Peshawar, Khyber Pakhtunkhwa
    Pakistan

    Active - Recruiting

  • Lady Reading Hospital

    Peshawar, Khyber Pakhtunkhwa 09152
    Pakistan

    Active - Recruiting

  • Medical Complex Swabi

    Swābi, Khyber Pakhtunkhwa
    Pakistan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.