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

Phase 3

Recruiting

Brief 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Ribavirin + Standard Treatment	Ribavirin	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.
Ribavirin + Standard Treatment	Standard Treatment	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.
Standard Treatment Alone	Standard Treatment	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.

Primary Outcome Measures

Name	Time	Method
Prevention of Clinically Significant Hemorrhage	Up to 7 days post-treatment initiation	Evaluate the efficacy of Ribavirin plus standard treatment compared to standard treatment alone in preventing clinically significant hemorrhage (WHO Grade 2 or higher).

Secondary Outcome Measures

Name	Time	Method
Platelet Count Changes	At baseline, Day 4, and Day 7 post-treatment initiation.	Compare levels of serum ferritin, C-reactive protein, and lactate dehydrogenase between the intervention and control groups.
Length of Hospital Stay	From hospital admission to discharge (up to 14 days).	Evaluate and compare the duration of hospitalization in the intervention and control groups.

Locations (4): Lady Reading Hospital
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Peshawar, Khyber Pakhtunkhwa, Pakistan
Gandhara Medical Hospital
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Peshawar, Khyber Pakhtunkhwa, Pakistan
Medical Complex Swabi
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Swābi, Khyber Pakhtunkhwa, Pakistan
Kohat Institute of Medical Science
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Kohat, KPK, Pakistan