Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI) (NCT06251089) | Clinical Trial Compass
CompletedNot Applicable
Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)
Spain102 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range
65 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects admitted to nursing home
* Subjects who have had a washing period of 2 months since the last use with mouthwashes.
* \> 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 Informed Consent (IC) to subjects or legal guardians of the subjects who agree to participate.
Exclusion Criteria:
* Subjects who are suffering from an upper or lower airway infection at the time of recruitment
* Subjects who are physically or psychologically unable to perform mouthwashes or receive 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 or legal guardians of subjects who do not provide their IC to participate Subjects who have a registered allergy to the product or to the excipients of the product.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.