Status:
COMPLETED
Trial To Assess Efficacy and Safety of PediaFlu® in Children With Acute Tonsillopharyngitis / Rhinopharyngitis
Lead Sponsor:
Pediatrica S.r.l
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Tonsillopharyngitis
Rhinopharyngitis
Eligibility:
All Genders
3-10 years
Phase:
NA
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04899401
Start Date
June 3 2021
End Date
August 12 2021
Last Update
September 8 2021
Active Locations (3)
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1
CMMF Dr. Morariu Bordea Maria
Timișoara, Timiș County, Romania, 300210
2
CM Dr. Herteg Dorina
Timișoara, Timiș County, Romania, 300288
3
CM Dr. Matei Cristian-Radu
Timișoara, Romania