RANDOMIZED, DOUBLE-BLIND, CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CEPHALEXIN 500MG + AMBROXOL HYDROCHLORIDE 30 MG (CEFABRONCOL® CAPSULES) COMPARED TO CEPHALEXIN 500 MG CAPSULES IN ADULT PATIENTS WITH ACUTE PHARYNGOTONSILLITIS.
- Registration Number
- PER-002-22
- Lead Sponsor
- MEDIFARMA S A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
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.
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.
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 ;Detection of antigens in culture of pharyngeal secretion<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