J030 Streptococcal tonsillitis Streptococcal tonsillitis
Conditions
Interventions
Each participant will receive 1 dose of Cefabroncol® powder for suspension at 40mg/kg/day every 12 hours for 10 days. -
Each participant will receive 1 dose of Cephalexin 250 mg
Sponsors
MEDIFARMA S A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients between 3 - 10 years old. 2. Clinical diagnosis of acute bacterial tonsillopharyngitis under medical criteria and following the recommendations of the American Academy of Pediatrics (1), which states that the patient must have at least 2 or more of the following symptoms: (i) absence of cough, (ii ) presence of tonsillar exudate or inflammation, (iii) history of fever, (iv) presence of swollen and tender anterior cervical lymph nodes, and (v) age less than 15 years. 3. Confirmation of the clinical diagnosis with the positive rapid antigen detection test for GABHS. 4. Signed informed consent form. 5. Signed informed assent form, where applicable (children from 8 to 10 years old). 6. Negative SARS-CoV-2 antigen test. 7. The parent or legal guardian must be able to understand, sign and date an informed consent document in accordance with the guidelines of good clinical practice and local regulations. In addition, she must be committed to comply with the assigned treatment and tests. 8. Desire to adhere to the treatment and follow-up program.
Exclusion criteria
Exclusion criteria: 1. Allergy to cephalosporins. 2. Concomitant respiratory infections such as acute otitis media, acute sinusitis, pneumonia, subpharyngeal infections, or tonsillar abscesses. 3. History of rheumatic heart disease or valvular dysfunction of unknown etiology. 4. Immunosuppression. 5. Skin rash. 6. History of chronic kidney disease or liver failure. 7. History of recurrent or recent pharyngotonsillitis (more than 3 episodes in the last 6 months or 1 episode in the last month). 8. Have received oral antibiotics in the last 7 days, prior to enrollment in the study. 9. History of hypersensitivity to ambroxol. 10. Concurrent treatment with another antibiotic or corticosteroids. 11. History of gastrointestinal disease, especially colitis associated with the use of antibiotics. 12. Patients who are receiving some anticoagulant treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Norrby Scale NAME OF THE RESULT: Clinical cure PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 10 ;Rapid antigen detection test for EßGA 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 |
|---|---|
| Norrby Scale NAME OF THE RESULT: Clinical cure PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 10 ;Rapid antigen detection test for EßGA 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 ;Wong–Baker scale. NAME OF THE RESULT: Reduction of pain intensity. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 2, 4 and 10. ;Norrby Scale. NAME OF THE RESULT: Total symptom resolution time. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 4 and 10. ;Adverse events reported in the CRF. NAME OF THE RESULT: Treatment safety. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 2, 4, 10 and 15. | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
MEDIFARMA S A
Outcome results
None listed