NCT03605862已完成3 期
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,756
- 试验地点
- 1
- 主要终点
- Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
研究概览
简要总结
Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
详细描述
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects at least 12 years of age
- •Presence of clinical signs and/or symptoms consistent with an acute illness compatible with EV/RV infection (each of the following is required):
- •Presence of moderate or severe rhinorrhea defined as "attempting to relieve nasal symptoms by blowing, wiping, or sniffling at least twice per hour for any one hour within 12 hours preceding study entry," AND
- •Presence of cough, sore throat or nasal obstruction.
- •Negative rapid influenza diagnostic test (required only if the subject has an oral temperature >100°F in the clinic or if the latest CDC weekly influenza report shows influenza prevalence "Regional" or higher for the institution's state). A result from a rapid influenza diagnostic test performed on the same day that informed consent is obtained will be sufficient to meet this criterion if documentation of test results is available as part of medical history.
- •Onset of illness no more than 40 hours before enrollment in the trial. Onset of illness is defined as the first time at which the subject experienced rhinorrhea, cough, sore throat or nasal obstruction.
- •Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the subject diary
排除标准
- •Persons requiring or anticipated to require in-hospital care
- •Cystic fibrosis
- •Cardiac arrhythmia
- •Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
- •Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
- •Persons with sickle cell anemia or other hemoglobinopathies
- •Poorly controlled insulin-dependent diabetes mellitus (HbA1C >8.0%)
- •Concurrent infection at the screening examination that requires systemic antimicrobial therapy
- •Females of childbearing potential who are either pregnant or sexually active without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
- •Females who are breastfeeding
- •Receipt of any dose of NTZ within 30 days prior to screening
- •Prior treatment with any investigational drug therapy within 30 days prior to screening
- •Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies
- •Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets
- •Subjects unable to take oral medications
- •Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary
研究组 & 干预措施
Nitazoxanide
Active Comparator
Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
干预措施: Nitazoxanide (Drug)
Placebo
Placebo Comparator
Two placebo tablets orally twice daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
时间窗: Up to 21 days
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.
次要结局
- Time From First Dose to Ability to Perform All Normal Activities(Up to 21 days)
- Proportions Experiencing Complications of EV/RV Infection(28 days)
研究者
研究点 (1)
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