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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
284
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.
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.
Lady Reading Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
Gandhara Medical Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
Medical Complex Swabi
Swābi, Khyber Pakhtunkhwa, Pakistan
Kohat Institute of Medical Science
Kohat, KPK, Pakistan
Prevention of Clinically Significant Hemorrhage
Evaluate the efficacy of Ribavirin plus standard treatment compared to standard treatment alone in preventing clinically significant hemorrhage (WHO Grade 2 or higher).
Time frame: Up to 7 days post-treatment initiation
Platelet Count Changes
Compare levels of platelets count between the intervention and control groups.
Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.
Length of Hospital Stay
Evaluate and compare the duration of hospitalization in the intervention and control groups.
Time frame: From hospital admission to discharge (up to 14 days).
C-reactive protein
Compare the C-reactive protein in between intervention and control group
Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.
Serum ferritin
Compare the serum ferritin in between intervention and control group
Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.
Lactate dehydrogenase
Compare levels of lactate dehydrogenase between the intervention and control groups.
Time frame: At baseline, Day 4, and Day 7 post-treatment initiation.
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