Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)

Phase

N/A

Condition

Pharyngitis

Respiratory Syncytial Virus (Rsv) Infection

Treatment

Placebo

CPC mouthwash

Clinical Study ID

NCT06251089

MTH_DEN0123

Ages 65-100
All Genders
Accepts Healthy Volunteers

Study Summary

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will receive either VITIS CPC Protect® mouthwash (Mouthwash with cetylpyridinium chloride (CPC) as an anti-plaque antiseptic at a concentration of 0.07%) or mouthwash without cetylpyridinium chloride, as control group Subjects included in the study will be followed for 90 days. Symptoms associated with vURTIs (viral upper respiratory tract infections) should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract.

Symptoms and adverse effects will be recorded when the episode occurs. The assignment as VURIs will be made by the investigator once the diaries have been completed, or during the symptoms if possible.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects admitted to nursing home
Subjects who have had a washing period of 2 months since the last use withmouthwashes.
> age 65
Subjects who are able to do mouthwashes or receive oral hygiene by caregivers
Delivery of the Participant Information Sheet (HIP) and signing of the InformedConsent (IC) to subjects or legal guardians of the subjects who agree toparticipate.

Exclusion

Exclusion Criteria:

Subjects who are suffering from an upper or lower airway infection at the time ofrecruitment
Subjects who are physically or psychologically unable to perform mouthwashes orreceive oral hygiene with gauze or cotton soaked in antiseptic
Subjects who have used oral antiseptics continuously in the past month
Use of oral hygiene measures outside the study conditions
Subjects who frequent residences, but are not admitted (e.g. day centre) Subjects orlegal guardians of subjects who do not provide their IC to participate Subjects whohave a registered allergy to the product or to the excipients of the product.

Study Design

Placebo

November 15, 2023

August 05, 2024

Study Description

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will be included. Allocation ratio (1:1). The trial will be offered to subjects who live in a nursing home and who can perform mouthwashes themselves or to whom healthcare professionals can apply the product.

Subjects included in the study will be followed for 90 days. Symptoms associated with vURTI should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. If such an infection exists (when three of the following symptoms are present: fever over 37º, non-productive cough, sore throat, runny nose, nasal congestion or malaise) the degree of severity will be determined and recorded.

Symptoms and adverse effects will be recorded when the episode occurs. The assignment as vURTI will be made by the investigator once the diaries have been completed, or during the symptoms if possible. Follow-up visits will be conducted fortnightly

Connect with a study center

EAP Baix Llobregat
Barcelona,
Spain
Site Not Available

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