Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis

Обзор

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.

Вмешательства

• Устройство HMG
  Patients included in the "HMG" arm will receive the medical device of the same name.
• Устройство PHN
  Patients included in the "PHN" arm will receive the medical device of the same name.
• Устройство PHR
  Patients included in the "PHR" arm will receive the medical device of the same name.
• Устройство TUR
  Patients included in the "TUR" arm will receive the medical device of the same name.

Первичные конечные точки

• Tolerance [Срок оценки: From visit 1 (day 1) to visit 2 (day 8)]

Вторичные конечные точки (4)

• Efficiency [Срок оценки: From visit 1 (day 1) to the last day of use of the study product (day 8)]
• Efficiency [Срок оценки: From visite 1 (day 1) to visit 2 (day 8)]
• Quality of life impact [Срок оценки: From visite 1 (day 1) to visit 2 (day 8)]
• Device defect [Срок оценки: From visit A (day 1) to visit 2 (day 8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Chu Clermont Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07569939 · RBHP 2026 PICKERING (PharyTol) · 2026-A00430-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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