PACTR202312770983740尚未招募2 期
Efficacy, tolerability and safety of new or repurposed drugs against Lassa Fever in West African countries: an adaptative phase II-III platform trial
Irrua Specialist Teaching Hospital0 个研究点目标入组 732 人开始时间: 2023年12月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 732
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •General Inclusion Criteria:
- •?Clinical disease with signs and symptoms suggestive for LF
- •?Positive plasma LASV RT-PCR
- •?Participant requires hospitalization per the local guidelines
- •?Participant or their legally authorized representative is able and willing to sign the informed consent
- •Each intervention arm has specific eligibility criteria
- •-->Favipiravir:
- •specific inclusion criteria
- •Age = 18 years old
- •-->Combinaison Favipiravir and Ribavirin
- •specific inclusion criteria
- •Age = 18 years old
- •--> Combinaison Ribavirin and Dexamethasone
- •specific inclusion criteria
- •Age = 12 years old
排除标准
- •?Unwilling to provide informed consent
- •?Positive pregnancy test
- •?History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document
- •?Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion
- •Each intervention arm has have specific eligibility criteria
- •--> Favipiravir:
- •specific exclusion criteria
- •Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- •Treatment contraindicated with favipiravir according to the Reference safety document
- •Pre-existing liver failure
- •Severe symptomatic gout/hyperuricemia
- •History of QT prolongation or arrhythmia or other cardiac disorders
- •PR interval = 200 ms
- •Hypersensitivity to excipients
- •Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- •--> Combinaison Favipiravir and Ribavirin
- •specific exclusion criteria
- •Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- •Treatment contraindicated with favipiravir according to the Reference safety document
- •Pre-existing liver failure
- •Severe symptomatic gout/hyperuricemia
- •History of QT prolongation or arrhythmia or other cardiac disorders
- •PR interval = 200 ms
- •Hypersensitivity to excipients
- •Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- •--> Combinaison Ribavirin and Dexamethasone
- •specific exclusion criteria
- •Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- •Known intolerance and contra-indications to ribavirin or dexamethasone
- •Patients who already received a corticosteroid within the preceding 7 days
研究者
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