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

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Viral Sore Throat; Acute Pharyngitis

Treatments: Device: TUR; Device: PHR; Device: PHN; Device: HMG

Study type: Interventional

Funder types: Other

Identifiers

NCT07569939

2026-A00430-51 (Other Identifier)

RBHP 2026 PICKERING (PharyTol)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

HMG

Experimental group

Description:

Patients included in the "HMG" arm will receive the medical device of the same name.

Treatment:

Device: HMG

PHN

Experimental group

Description:

Patients included in the "PHN" arm will receive the medical device of the same name.

Treatment:

Device: PHN

PHR

Experimental group

Description:

Patients included in the "PHR" arm will receive the medical device of the same name.

Treatment:

Device: PHR

TUR

Experimental group

Description:

Patients included in the "TUR" arm will receive the medical device of the same name.

Treatment:

Device: TUR