Clinical trial NCT04899401: Trial To Assess Efficacy and Safety of PediaFlu® in Children With Acute Tonsillopharyngitis / Rhinopharyngitis
Official title: A Randomized, Open, Controlled Study to Evaluate the Efficacy and Safety of PediaFlù® (Dietary Supplement) Along With Standard of Care in Children With Acute Tonsillopharyngitis / Rhinopharyngitis Versus Standard of Care Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillopharyngitis
Rhinopharyngitis
Keywords: ATP
tonsillopharyngitis
Rhinopharyngitis
PediaFlù®
Pelargonium sidoides
Propolis
Lead sponsor: Pediatrica S.r.l
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2021-05-24
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, multicenter clinical investigation, with two parallel groups of subjects.
Primary purpose: TREATMENT

Brief summary: Sore throat or acute tonsillopharyngitis, often referred to as angina catarrhalis in Central and Eastern Europe, affects mainly children, adolescents and young adults and represents one of the most common reasons to consult a family physician. While most patients complaining of sore throats have an infection, it has been estimated that fewer than 20% present with a clear indication for antibiotic therapy, i.e., are positive for hemolytic streptococcus.

Acute tonsillopharyngitis (ATP) is a highly prevalent, seasonal infective disorder characterized by an inflammation of the pharynx and the palatine tonsils, which occurs in all age groups and accounts for about 5% of all visits in pediatric care. Common symptoms of ATP include sore throat, dysphagia, red pharynx, enlarged tonsils sometimes covered with exudate, fever with sudden onset, malaise, gastrointestinal complaints, halitosis, rhinorrhea and cough. Children with non-streptococcal tonsillopharyngitis are often over-treated with antibiotics.

The scientific literature currently available shows that the extract of Pelargonium sidoides may be effective in the treatment of disorders affecting the respiratory tract.

Evidence shows that zinc is beneficial for the common cold in healthy children and adults living in high-income countries and it may inhibit replication of the virus. In addition, zinc (lozenges or syrup) reduces the average duration of the common cold in healthy people assuming zinc within 24 hours of onset of symptoms Propolis has been widely investigated for its antibacterial, antiviral, and anti-inflammatory properties and is administered as an add-on therapy during watchful waiting for better control of symptoms in non-streptococcal pharyngitis.

The above-mentioned considerations, have suggested Pediatrica Srl to develop a food supplement specific for pediatric age for the well-being of the airways (PediaFlù®). This product is actually on the market as adjuvant in seasonal diseases.

The present clinical investigation is planned to verify and confirm these encouraging results in a setting of standard clinical practice.

This is a randomized, open, controlled study to evaluate the efficacy and safety of PediaFlù® (dietary supplement) along with standard of care in children with acute tonsillopharyngitis / rhinopharyngitis versus standard of care only.

The primary objective is to evaluate the efficacy and safety of the tested dietary supplement administered along with standard care vs standard care alone in children affected by acute tonsillopharyngitis (ATP).

The secondary objectives of the study are the assessment of the use of rescue medicine (Ibuprofen or high dose of Paracetamol) and the evaluation of the overall improvement symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients will be eligible for inclusion if all the following criteria are respected:
* male and female (children 3 - 10 years old);
* acute tonsillitis / rhinopharyngitis (sore throat, catarrhal angina), duration of complaints ≤ 48 hours,
* Absence of pharyngeal exudate and/or Mc Isaac score 0-1 + negative rapid test for β-hemolytic streptococcus and SARS-CoV-2 identification
* tonsillitis symptoms score (TSS) ≥ 8 points,
* both parents capable of and freely willing to provide written informed consent prior to participating in the clinical investigation.
* for children above 6 years old capable willing to provide written informed consent prior to participating in the clinical investigation.

Exclusion Criteria:

* evidence of lacunar or follicular angina.
* more than two episodes of tonsillitis within the last 12 months,
* mandatory indication for therapy with antibiotics (e.g., abscess, septic tonsillitis, history of rheumatic fever, post-streptococcus glomerulonephritis, and chorea minor Sydenham),
* history of close contact with SARS-COV-2 infected individuals in the last 10 days before symptoms onset
* treatment with antibiotics within 4 months prior to study inclusion,
* increased hemorrhagic diathesis, chronic diseases (e.g. severe heart, kidney or liver diseases), immunosuppression,
* known or suspected hypersensitivity to study medication,
* concomitant treatment potentially influencing study outcome or known interactions with study medication (e.g., coumarin derivatives),
* participation in another clinical study within the last 3 months prior to clinical investigation inclusion.

Primary outcomes:
measure: Tonsillitis severity score
timeFrame: 6 days
measure: Number of treatment failure
timeFrame: 6 days
measure: AE/SAE incidence.
timeFrame: 6 days
Secondary outcomes:
measure: Compliance
timeFrame: 6 days
measure: Symptoms improvement
timeFrame: 6 days
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: CMMF Dr. Morariu Bordea Maria
state: Timis
city: Timişoara
country: Romania
facility: CM Dr. Herteg Dorina
state: Timis
city: Timişoara
country: Romania
facility: CM Dr. Matei Cristian-Radu
Study officials:
References: