Comparing standard treatment with and without Ribavirin for dengue fever
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
This study is testing if adding Ribavirin to the usual treatment for dengue fever can help prevent serious bleeding in patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 4 sites (Peshawar, Khyber Pakhtunkhwa and 3 other locations) |
| Trial ID | NCT06744777 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding Ribavirin to standard treatment in preventing significant bleeding in patients with dengue fever. It is a double-blind, randomized controlled trial that aims to determine if Ribavirin improves clinical outcomes compared to standard treatment alone. Conducted in multiple hospitals in Khyber Pakhtunkhwa, the trial employs rigorous methodologies including block randomization and double-blinding. Key outcomes measured include changes in bleeding severity, platelet counts, and length of hospital stay, with the goal of enhancing dengue management protocols.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults aged 18 and older diagnosed with dengue fever confirmed by specific laboratory tests.
Not a fit: Patients with bleeding disorders, those on anticoagulant medications, or pregnant women are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of severe bleeding in dengue patients, improving their overall clinical outcomes.
How similar studies have performed: While the approach of using Ribavirin in dengue treatment is being explored, this specific comparative efficacy study is novel and has not been extensively tested in previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Peshawar, Khyber Pakhtunkhwa and 3 other locations
- Lady Reading Hospital — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
- Gandhara Medical Hospital — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
- Medical Complex Swabi — Swābi, Khyber Pakhtunkhwa, Pakistan (Recruiting)
- Kohat Institute of Medical Science — Kohat, Kpk, Pakistan (Recruiting)
Study contacts
- Principal investigator: Said Amin, MBBS,FCPS — Department of Medicine Hayatabad Medical Complex Peshawar
- Study coordinator: Said Amin, MBBS, FCPS
- Email: saidamin@live.com
- Phone: +92-333-9115488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.