Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Tolerance
研究概览
简要总结
The objective of this study is to conduct post-marketing clinical follow-up of four products: HMG, PHN, PHR, and TUR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of sore throats related to acute pharyngitis and/or viral-origin tonsillitis, while also assessing the benefit/risk ratio of the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pharyngitis or tonsillitis or acute nasopharyngitis or viral-origin sore throat with odynophagia that began less than 72 hours before the inclusion visit according to the investigator's judgment
- •Bacterial rhinopharyngitis with negative TROD test
- •Effective contraception for female patients of childbearing age
- •Cooperation and sufficient understanding to comply with the requirements of the trial
- •Acceptance of registration in the SI-RIPH database
- •Having received informed information and agreeing to give written consent
- •Affiliated with the French Social Security scheme.
排除标准
- •Hypersensitivity/previous allergy to any of the product components,
- •Pharyngitis or tonsillitis or acute rhinopharyngitis complicated (phlegmon, acute otitis media, pneumonia…) or severely intolerable cough,
- •Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations,
- •Other ongoing treatments for acute pharyngitis or tonsillitis (local treatment, antibiotics, corticosteroids, antiretroviral…),
- •Comorbidities or health conditions deemed incompatible with the trial by the investigator,
- •Recent otorhinolaryngology surgery (<6 months),
- •Pulmonary pathology (Chronic Obstructive Pulmonary Disease, asthma…),
- •Immunosuppression (according to patient's report),
- •Pregnant or breastfeeding women,
- •Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial,
- •Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).
研究组 & 干预措施
PHR
Patients included in the "PHR" arm will receive the medical device of the same name.
干预措施: PHR (Device)
PHN
Patients included in the "PHN" arm will receive the medical device of the same name.
干预措施: PHN (Device)
TUR
Patients included in the "TUR" arm will receive the medical device of the same name.
干预措施: TUR (Device)
HMG
Patients included in the "HMG" arm will receive the medical device of the same name.
干预措施: HMG (Device)
结局指标
主要结局
Tolerance
时间窗: From visit 1 (day 1) to visit 2 (day 8)
Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book
次要结局
- Efficiency(From visit 1 (day 1) to the last day of use of the study product (day 8))
- Efficiency(From visite 1 (day 1) to visit 2 (day 8))
- Quality of life impact(From visite 1 (day 1) to visit 2 (day 8))
- Device defect(From visit A (day 1) to visit 2 (day 8))