Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (NCT02483260) | Clinical Trial Compass
By InvitationNot Applicable
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever
Germany30 participantsStarted 2016-06-16
Plain-language summary
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever?
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Adverse reactions
Timeframe: 5 years
Trial details
NCT IDNCT02483260
SponsorU.S. Army Medical Research and Development Command