A randomized, double-blind clinical study to evaluate the efficacy and safety of Cephalexin 250mg + Ambroxol hydrochloride 15mg (Cefabroncol®, powder for suspension) compared to Cephalexin 250mg (powder for suspension) in pediatric patients with Acute Bacterial Pharyngotonsillitis.
- Conditions
- J030 Streptococcal tonsillitisStreptococcal tonsillitisJ030
- Registration Number
- PER-030-22
- Lead Sponsor
- MEDIFARMA S A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method orrby Scale<br> NAME OF THE RESULT: Clinical cure<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Day 10 ;Rapid antigen detection test for EßGA<br> NAME OF THE RESULT: Microbiological cure<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Day 15
- Secondary Outcome Measures
Name Time Method