WithdrawnPhase 2

Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany

Stopped: Lack of enrollment

Germany0Started 2009-10

Plain-language summary

This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and Dobrava viruses. Treatment consists mainly of supportive care with careful attention to control of blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS (determination if the disease is caused by Puumala or Dobrava virus is helpful) and a history that makes exposure likely. This study will monitor the clinical events that occur with HFRS as well as the safety and efficacy of Ribavirin.

Who can participate

Age range17 Years – 65 Years

SexALL

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Inclusion criteria

✓. Meets the case definition for a probable or suspected case.
✓. 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 Event, Serious and Unexpected Adverse Events which may or may not be associated with administration of the drug for the duration of the study.
✓. Agrees to a follow-up visit and to donate blood and urine specimens at day 10, day 14 and between days 28 and 60 after their 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 has a negative pregnancy test and agrees not to become pregnant during treatment and for 7 months after receiving Ribavirin. Treatment will be a maximum of 25 doses given over a one week time period. At least two reliable forms of effective contraception, including one barrier method, must be utilized during treatment and during the 7 months post-treatment period.

Exclusion criteria

What they're measuring

Number of subject who develop oliguria

Timeframe: 5 years

Number of mortalities

Timeframe: 5 years

Trial details

NCT IDNCT00868946

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Hemorrhagic Fever With Renal Syndrome trials