💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).