The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever: A Double-blind, Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 4
- 主要终点
- Prevention of Clinically Significant Hemorrhage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind methodology, with randomization and treatment assignment concealed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Ribavirin + 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.
干预措施: Ribavirin (Drug)
Ribavirin + 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.
干预措施: Standard Treatment (Other)
Standard Treatment Alone
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.
干预措施: Standard Treatment (Other)
结局指标
主要结局
Prevention of Clinically Significant Hemorrhage
时间窗: 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).
次要结局
- Platelet Count Changes(At baseline, Day 4, and Day 7 post-treatment initiation.)
- Length of Hospital Stay(From hospital admission to discharge (up to 14 days).)
- C-reactive protein(At baseline, Day 4, and Day 7 post-treatment initiation.)
- Serum ferritin(At baseline, Day 4, and Day 7 post-treatment initiation.)
- Lactate dehydrogenase(At baseline, Day 4, and Day 7 post-treatment initiation.)