NCT02483260暂停不适用
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever)
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse reactions
研究概览
简要总结
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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 Exclusion Criteria: At the principal investigator's (PI) discretion, an individual may be treated with IV ribavirin, with caution, if one or more of these criteria are present.
- •A positive pregnancy test. The patient will be informed of the risk and benefit of treatment with IV ribavirin versus no ribavirin treatment for CCHF (generally associated with high mortality) and severe cases of Lassa fever (high mortality rates) versus mild cases of Lassa fever (low mortality rates).
- •A New York Heart Association cardiac functional capacity of Class II or greater for atherosclerotic heart disease (ASHD) and congestive heart failure (CHF).
- •Known cardiac defects that may predispose the subject to bradyarrhythmias, such as second or third degree heart block or sick sinus syndrome without a pacemaker, but capability of pacemaker placement, if needed.
- •Sinus bradycardia of 41-49 beats per minutes, if the individual is not known to have a low resting heart rate related to physical conditioning.
- •Use of drugs known to result in bradyarrhythmias (certain beta blockers and calcium channel blockers, digoxin, as well as clonidine, cholinesterase inhibitors, and lithium).
- •History of gout
研究组 & 干预措施
10-day course of treatment
Other
10-day course of treatment with follow-up 14 ± 2 days after first dose
干预措施: Ribavirin (Drug)
结局指标
主要结局
Adverse reactions
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
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