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

Khyber Medical University Peshawar

Status and phase: Completed; Phase 3

Conditions: Dengue Hemorrhagic Fever; Dengue Fever; Severe Dengue

Treatments: Drug: Ribavirin; Other: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06744777

KMU/DIR/CTU/2024/012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 WHO dengue severity classification.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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284 participants in 2 patient groups

Ribavirin + Standard Treatment

Experimental group

Description:

Participants in this group will receive the standard treatment for dengue fever alongside Ribavirin. Ribavirin will be administered orally at a dose of 15 mg/kg body weight twice daily (BD) for a total duration of 7 days.

Treatment:

Other: Standard Treatment

Drug: Ribavirin

Standard Treatment Alone

Active Comparator group

Description:

Participants in this group will receive only the standard treatment for dengue fever, which includes supportive care such as intravenous fluids and platelet transfusions, as required. No additional pharmacological intervention will be provided.

Treatment:

Other: Standard Treatment