CTRI/2018/09/015824尚未招募2 期
Safety and Efficacy of 5-aminolevulinic acid hydrochloride (5-ALA-HCl) and Sodium Ferrous Citrate (SFC) in patients with uncomplicated plasmodium falciparum malaria
eopharma Japan Co Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Weighing 40 to 90 kg
- •2. Women with child bearing potential willing to give consent for pregnancy test.
- •3.Patients and spouse/partner who is of childbearing potential must be using 2 acceptable methods of contraception one of which must be a physical barrier method, (eg. Spermicidal gel plus condom; condom plus partner is sterilized at least 6 months prior) for the entire study duration.
- •4. Presence of symptomatic uncomplicated P. falciparum with a
- •diagnosis confirmed by:
- •microscopically confirmed parasite infection, between 1000 and
- •100,000 asexual parasite count/μl of blood
- •fever, as defined by axillary/tympanic of >= 37.5°C or
- •oral/rectal/temperature of >= 38.0°C, or history of fever
- •within previous 24 hours (must be documented)
- •5. Patients must be willing and able to give written informed consent and comply with all study visits and procedures.
排除标准
- •1. Patients with signs and symptoms of severe/complicated malaria
- •requiring parenteral treatment according to the World Health
- •Organization Criteria 2010
- •2. Severe vomiting, defined as more than three times in the 24 hours
- •prior to inclusion in the trial or inability to tolerate oral treatment
- •3. Presence of febrile conditions caused by diseases other than malaria
- •4. Known history of photo-hypersensitivity, porphyria, or
- •hemochromatosis
- •5. Have taken any medication with antimalarial or antibiotic with
- •antimalarial effect in previous 14 days
- •6. Received an investigational drug within the past 4 weeks
- •7. Patients whose Hb level is lower than 8 g/dL
- •8. Liver function tests [AST/ALT levels] more than 2.5 times upper
- •limit of normal values
- •9. Known significant renal impairment as indicated by serum creatinine
- •of >= 1.4 mg/dL or eGFR of < 45 mL/min.
研究者
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