MULTICENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND CLINICAL TRIAL OF SUPERIORITY IN EFFICACY AND SAFETY OF THE FIXED-DOSE COMBINATION OF CEPHALEXIN AND AMBROXOL (BIOBRONCOL®) VERSUS CEPHALEXIN IN THE TREATMENT OF ACUTE BACTERIAL PHARYNGOTONSILLITIS IN THE PEDIATRIC POPULATION.

Not Applicable

• Conditions: -J039 Acute tonsillitis, unspecified; Acute tonsillitis, unspecified; J039

• Registration Number: PER-063-20
• Lead Sponsor: Instituto Quimioterapico S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Study Completion: 2021-08-11
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 179

Inclusion Criteria

- Patients between 2 - 15 years
- Clinical diagnosis of bacterial pharyngotonsillitis (4 or more McIsaac Modified Centor criteria) with rapid antigenic detection test for positive or negative GABHS, or less than 4 McIsaac Modified Centor criteria with positive GABHS rapid antigenic detection test.
- Signed informed consent form.
- SARS COV-2 Negative Rapid Test

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
- Compromise of kidney or liver function.
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation by the Norby et al GABHS symptom Assessment Scale for pharyngotonsillitis, and the microbiological evaluation by the rapid antigenic detection test for GABHS<br>Measure:Assess efficacy of BIOBRONCOL® (Cephalexin + Ambroxol) Powder for Oral Suspension in the treatment of acute pharyngotonsillitis.<br>Timepoints:3rd, 11th and 15th days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Norrby et al scale<br>Measure:Early resolution of symptoms in a patient with acute pharyngotonsillitis on day 3<br>Timepoints:3rd day<br>