A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents With Acute Uncomplicated Influenza
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects
研究概览
简要总结
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.
详细描述
A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the time to resolution of all clinical symptoms of influenza.
The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events and laboratory safety tests.
Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nitazoxanide, Placebo
300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days
干预措施: Nitazoxanide (Drug)
Nitazoxanide, Nitazoxanide
Two 300 mg nitazoxanide tablets(600mg) twice daily for 5 days
干预措施: Nitazoxanide (Drug)
Placebo
2 placebo tablets twice daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects
时间窗: Up to 28 days
The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection
次要结局
- Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline(7 days)
- Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects(at least 28 days)
- Time to Return to Normal Daily Activities(28 days)
- Time Loss From Work(28 days)
- Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B(28 days)
- Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline(7 days)
- Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)(28 days)
- Symptom Severity Score Hours(28 days)
- Complications of Influenza(28 days)
- Influenza Antibody Response Titer Change: Influenza A 2009 H1N1(28 days)
- Influenza Antibody Response: Influenza A H3N2(28 days)
- Influenza Antibody Response: Influenza B(28 days)
- Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1(28 days)
- Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2(28 days)