A Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care in Patients Hospitalized for Babesiosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Time to sustained clinical resolution
研究概览
简要总结
This study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.
详细描述
This study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.
Patients hospitalized for a diagnosis of babesiosis, who have received A/A for <48 hours (h) prior to randomization or are about to receive A/A, will be asked to provide written informed consent and will undergo eligibility screening including medical history, physical examination, prior and concomitant medications, blood chemistry and hematology, glucose-6-phosphate dehydrogenase (G6PD) deficiency testing, blood smear for diagnostic confirmation of babesiosis, pregnancy testing for females of child-bearing potential, and assessment of risk factors for relapsing babesiosis. The screening period will last a maximum of two days. The first day of dosing with TQ or placebo will be Day 1 and will be done while the patient is still hospitalized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥ 18 years.
- •Laboratory confirmed infection with Babesia.
- •Exhibiting at least one self-reported clinical symptoms of babesiosis.
- •Able and willing to give written informed consent.
- •Expected to be hospitalized at the time of or following informed consent and still hospitalized on the day of randomization and start of investigational products.
- •Willing to complete the study activities and assessments.
- •Must agree not to enroll in another study of an investigational agent prior to completion of the study.
- •Able to take oral medications.
- •If female of reproductive age, must agree to use an acceptable method of birth control.
- •Adequate venous access.
- •Blood hemoglobin ≥ 7 g/dL.
排除标准
- •Have any contraindications to TQ.
- •Have any contraindication for azithromycin or atovaquone.
- •Any concomitant significant illness unrelated to babesiosis.
- •Receipt of any experimental treatment for babesiosis.
- •Taking any excluded concomitant medication.
- •Current or planned treatment with quinine while participating in the study.
- •Positive pregnancy test.
- •If A/A was initiated more than 48h prior to randomization and parasitemia is not >1%.
- •Azithromycin or atovaquone administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease.
研究组 & 干预措施
Group 1
TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4
干预措施: Tafenoquine (Drug)
Group 2
Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4
干预措施: Placebo (Other)
结局指标
主要结局
Time to sustained clinical resolution
时间窗: Day 1 to 90
Time to sustained clinical resolution of all the following symptoms of babesiosis: sweats, joint aches, cough, loss of appetite, muscle aches, headache, chills or shivering, feeling hot or feverish, nausea, fatigue (low energy or tiredness), and vomiting. The time to achieve sustained clinical resolution will be the date when patients first self-report a 7-day period without these symptoms relative to the start of tafenoquine or placebo treatment.
次要结局
- Difference in TTMC between TQ and placebo(Day 1 to 90)