MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND CLINICAL TRIAL OF SUPERIORITY IN EFFICACY AND SAFETY OF THE FIXED-DOSE COMBINATION OF AMOXICILLIN AND AMBROXOL (AMBROXIL®) VERSUS AMOXICILLIN IN THE TREATMENT OF ACUTE BACTERIAL PHARYNGITIS IN THE PEDIATRIC POPULATION.
- Conditions
- -J039 Acute tonsillitis, unspecifiedAcute tonsillitis, unspecifiedJ039
- Registration Number
- PER-062-20
- Lead Sponsor
- Instituto Quimioterapico S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 292
Patients between 2 - 15 years
- Clinical diagnosis of bacterial pharyngotonsillitis (4 or more McIsaac Modified Centor criteria) with rapid antigenic detection test for positive or negative GABHS, or less than 4 McIsaac Modified Centor criteria with positive GABHS rapid antigenic detection test.
- Signed informed consent form.
- Negative SARS COV-2 Rapid Test
- Concomitant respiratory infections such as acute otitis media, acute sinusitis, pneumonia, subpharyngeal infections or tonsillar abscesses.
- History of rheumatic heart disease or valve dysfunction of unknown etiology
- Immunosuppression
-Skin rash
- Compromise of kidney or liver function.
- Patients with some type of cancer.
- History of recurrent or recent pharyngotonsillitis (more than 3 episodes in the last 6 months or 1 episode in the last month)
- Have received oral antibiotics in the last 7 days prior to enrollment in the study or have received cephalosporins in the last three months.
- History of hypersensitivity to amoxicillin or type 1 hypersensitivity to penicillin.
- History of hypersensitivity to ambroxol.
- Pregnancy or lactation.
- Concurrent treatment with another antibiotic or with corticosteroids.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method