Dengue Fever, Dengue Hemorrhagic Fever, Severe Dengue
Conditions
Keywords
Dengue, Hemorrhage, Randomized Controlled Trial, Antiviral Therapy
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.
Interventions
DRUGRibavirin
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.
OTHERStandard 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
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind methodology, with randomization and treatment assignment concealed.
Intervention model description
The study employs a parallel group design, where participants are randomly assigned to one of two arms: an intervention group receiving standard treatment plus Ribavirin and a control group receiving standard treatment alone. This approach ensures that each participant is exposed to only one of the two interventions being compared. The study is designed to assess the comparative efficacy of Ribavirin in preventing clinically significant hemorrhage among dengue fever patients while minimizing confounding factors through randomization and blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Platelet Count Changes | At baseline, Day 4, and Day 7 post-treatment initiation. | Compare levels of platelets count 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. |
| Serum ferritin | At baseline, Day 4, and Day 7 post-treatment initiation. | Compare the serum ferritin in between intervention and control group |
| Lactate dehydrogenase | At baseline, Day 4, and Day 7 post-treatment initiation. | Compare levels of lactate dehydrogenase between the intervention and control groups. |
| C-reactive protein | At baseline, Day 4, and Day 7 post-treatment initiation. | Compare the C-reactive protein in between intervention and control group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Tolerability of Ribavirin | During the 7-day treatment period and up to 30 days post-treatment follow-up. | Document adverse events, including side effects, and assess the tolerability of Ribavirin in the intervention group. |
Countries
Pakistan
Outcome results
None listed