J03 NULL NULL
Conditions
Interventions
Each participant will receive two daily doses of cephalexin 500 mg + ambroxol 30 mg, every 12 hours for 10 days. -
Each participant will receive two daily doses of Cefalexin 500
Sponsors
MEDIFARMA S A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 6. Be able to understand, sign and date an informed consent document in accordance with the guidelines of good clinical practice and local regulations. 7. Commitment to comply with assigned treatment and tests. 8. Desire to adhere to the treatment and follow-up program. 2. Clinical diagnosis of acute pharyngotonsillitis with at least 3 criteria of the FeverPAIN scale. 3. Positive rapid antigen detection test for GABHS. 4. Signed informed consent form. 5. SARS COV-2 antigenic test Negative. 1. Research subjects women and men between 18 - 75 years.
Exclusion criteria
Exclusion criteria: 5. Skin rash. 6. History of chronic kidney disease or liver failure. 7. History of recurrent or recent bronchitis (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 study enrollment. 9. History of hypersensitivity to ambroxol. 10. Pregnancy or breast feeding. 11. Concurrent treatment with another antibiotic or corticosteroids. 12. History of gastrointestinal disease, especially colitis associated with the use of antibiotics. 13. Research subjects who are receiving any anticoagulant treatment. 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. Inmunodepression.
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 ;Detection of antigens in culture of pharyngeal secretion 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 ;Norrby Scale. NAME OF THE RESULT: Time to full resolution of symptoms. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3, 7 y 10. ;Visual analog scale. NAME OF THE RESULT: Improvement of pain intensity. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3, 7 y 10. ;Norrby Scale. NAME OF THE RESULT: Symptom improvement. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3, 7 y 10. ;Detection of antigens in culture of pharyngeal secretion 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 ;Adverse events reported in the CRF. NAME OF THE RESULT: Adverse event frequency. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During the treatment time and the follow-up period. | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
MEDIFARMA S A
Outcome results
None listed