Clinical trial NCT06744777: The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Severe Dengue
Keywords: Dengue
Hemorrhage
Randomized Controlled Trial
Antiviral Therapy
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Prevention of Clinically Significant Hemorrhage
timeFrame: Up to 7 days post-treatment initiation
Secondary outcomes:
measure: Platelet Count Changes
timeFrame: At baseline, Day 4, and Day 7 post-treatment initiation.
measure: Length of Hospital Stay
timeFrame: From hospital admission to discharge (up to 14 days).
Other outcomes:
measure: Adverse Events and Tolerability of Ribavirin
timeFrame: During the 7-day treatment period and up to 30 days post-treatment follow-up.
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
state: Khyber Pakhtunkhwa
city: Peshawar
country: Pakistan
facility: Gandhara Medical Hospital
state: Khyber Pakhtunkhwa
city: Swābi
country: Pakistan
facility: Medical Complex Swabi
state: Khyber Pakhtunkhwa
city: Kohat
country: Pakistan
facility: Kohat Institute of Medical Science
state: KPK
Study officials:
affiliation: Department of Medicine Hayatabad Medical Complex Peshawar
name: Said Amin, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Public Health and Social Science, Khyber Medical University Peshawar
name: Sheraz Fazid, MBBS,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Public Health and Social Science, Khyber Medical University Peshawar
name: Noman Arif, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kohat Institute of Medical Science Peshawar Pakistan
name: Akhtar Sherin, MBBS,MHR,PHD
role: PRINCIPAL_INVESTIGATOR
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