J039 Acute tonsillitis, unspecified Acute tonsillitis, unspecified
Conditions
Interventions
AMOXICILLLIN 500 MG + AMBROXOL 30 MG, TABLETS FOR ORAL ADMINISTRATION, EVERY 08 HOURS FOR 10 DAYS. -
Sponsors
Instituto Quimioterapico S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients between 18 - 80 years old -Clinical diagnosis of bacterial pharyngotonsillitis (4 or more criteria of Modified Centor by McIsaac) with rapid antigenic detection test for positive GABHS, or less than 4 criteria of Modified Centor by McIsaac with rapid antigenic detection test for positive GABHS. -Signed informed consent form. -Rapid SARS COV-2 Test Negative
Exclusion criteria
Exclusion criteria: -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 - Medical history of kidney disease or liver failure. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for assessing the intensity of symptoms of group A-beta hemolytic streptococcus tonsillopharyngitis NAME OF THE RESULT: Resolution of the severity of symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3,10, 15;rapid antigen detection test for GABHS NAME OF THE RESULT: Microbiological cure PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Scale for assessing the intensity of symptoms of group A-beta hemolytic streptococcus tonsillopharyngitis NAME OF THE RESULT: Resolution of the severity of symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3,10, 15;rapid antigen detection test for GABHS NAME OF THE RESULT: Microbiological cure PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 15;Scale for assessing the intensity of symptoms of group A-beta hemolytic streptococcus tonsillopharyngitis NAME OF THE RESULT: early resolution of symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3;Report in CRF NAME OF THE RESULT: Report of serious adverse events PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: during the 15 days | — |
Countries
Peru
Outcome results
None listed