Viral Hemorrhagic Fever
Conditions
Brief summary
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever?
Detailed description
To provide an intravenous ribavirin therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or Lassa fever.
Interventions
DRUGRibavirin
1. Loading dose, 33 mg/kg (maximum dose: 2.64 g) 2. Followed in 6 hours by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses) 3. Followed by a dose of 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 6 days (18 doses).
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets the case definition for a probable or a suspected case of CCHF or LF * Must be DoD-affiliated personnel including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents as well as allied military forces and local nationals who have been granted access to the medical facility * Is at least 18 years of age (17, if active military) and not greater than 65 years of age * Has a blood sample drawn and a type and cross-match ordered for transfusion * Has a hemoglobin greater than or equal to10 g/dL before starting IV ribavirin * Agrees to collection of required specimens * Agrees to report any adverse events for the duration of the protocol * Agrees to a follow-up visit and to donate blood and urine specimens at Day 14 (±2 days) after the first dose of IV ribavirin and agrees to all follow-up visits for anemia or other medical conditions as required by the attending physician * Female patient of childbearing potential must have a pregnancy test. Patient will be counseled concerning the risks of IV ribavirin versus no treatment if the pregnancy test is positive. If the test is negative, patient agrees to take precautions to avoid pregnancy during treatment and for 7 months after treatment. * Male patient agrees not to have intercourse with a pregnant woman and to take precautions to avoid producing pregnancies during treatment and for 7 months after ribavirin treatment. * Female patient agrees not to breastfeed during treatment and for 7 months after ribavirin treatment
Exclusion criteria
* • Has known intolerance to ribavirin. * Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission). * Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV ribavirin * Has history of hemoglobinopathies (ie, sickle-cell anemia or thalassemia major). * Has history of autoimmune hepatitis. * Has serum calculated creatinine clearance of \< 30 mL/min. * History of second or third degree heart block or sick sinus syndrome without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome. * A sinus bradycardia of less than 40 beats per minute (see below). * Is currently being treated with didanosine (ddI). ddI must be discontinued before starting IV ribavirin. Relative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions | 5 years |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORJoshua Hawley-Molloy, MD
Landstahl Regional Medical Center
Outcome results
None listed