Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities (NCT00992693) | Clinical Trial Compass
WithdrawnPhase 2
Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities
Germany0Started 2009-09
Plain-language summary
This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.
Who can participate
Age range17 Years – 65 Years
SexALL
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Inclusion Criteria:
An individual will be enrolled in this study if the patient:
* Meets the case definition for a probable or a suspected case of CCHF or LF (see below).
* Has read and signed the Informed Consent.
* 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.
* Agrees to collection of required specimens.
* Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study.
* Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician.
* Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive.
* Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid …
What they're measuring
1
Number of adverse events
Timeframe: 5 years
2
Number of deaths of individuals with viral hemorrhagic fever (Crimean-Congo hemorrhagic fever or Lassa fever) who received at least four doses of IV Ribavirin
Timeframe: 5 years
Trial details
NCT IDNCT00992693
SponsorU.S. Army Medical Research and Development Command