130
Participants
Start Date
June 3, 2021
Primary Completion Date
August 12, 2021
Study Completion Date
August 12, 2021
Standard of care + PediaFlù®
Standard of care: Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. PediaFlù®: During the 6 days of the clinical investigation, the subjects will administer PediaFlù® 5ml x3 times per day for children below 6 years and 10mlx3 times per day for children above 6 years.
Standard of care
Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. Standard of care Nasopharyngeal liberation through hydration with drinking fluids to support body fluid excretion, aspiration of secretions, NaCl solution for nasal irrigation, Nasal sprays with sea water, nasal spray with active compound (to be used only at special indication of the medical doctor) Throat spray with Benzydamine hydrochloride (Tantum Verde®), Pediatric use: children over 6 and below 12: 4 sprays 2 - 6 times a day. Children (under 6 years): 1 spray per 4 kg of body weight, a maximum of 4 sprays at once, 2-6 times a day according to the leaflet. Each spray equals 0.17 ml of solution. Acetaminophen (Paracetamol) per os: at need, as antipyretic (\>38,5C), 10 mg/kg/dose, per need every 6-8 hours or according to the leaflet, maximum dosage 80 mg / kg / day. A dosage of over 30 mg/Kg/dose will result in an IP failure;
CMMF Dr. Morariu Bordea Maria, Timișoara
CM Dr. Herteg Dorina, Timișoara
CM Dr. Matei Cristian-Radu, Timișoara
Opera CRO, a TIGERMED Group Company
OTHER
Pediatrica S.r.l
OTHER