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 ADULTS

Not Applicable

Recruiting

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

• Registration Number: PER-103-20
• Lead Sponsor: Instituto Quimioterapico S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-03
• Study Completion: 2022-06-28
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

-Patients between 18 - 80 years old
-Clinical diagnosis of bacterial pharyngotonsillitis (4 or more criteria of Modified Centor by McIsaac) with rapid antigenic detection test for positive GABHS, or less than 4 criteria of Modified Centor by McIsaac with rapid antigenic detection test for positive GABHS.
-Signed informed consent form.
-Rapid SARS COV-2 Test Negative

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
-Medical history of kidney disease or liver failure.
-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:Scale for assessing the intensity of symptoms of group A-beta hemolytic streptococcus tonsillopharyngitis<br>Measure:Resolution of the severity of symptoms<br>Timepoints:Day 3,10, 15<br>;<br>Outcome name:Rapid antigenic detection test for GABHS<br>Measure:Microbiological cure<br>Timepoints:Day 15<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Scale for assessing the intensity of symptoms of group A-beta hemolytic streptococcus tonsillopharyngitis<br>Measure:early resolution of symptoms<br>Timepoints:Day 3<br>;<br>Outcome name:Report in CRF<br>Measure:Report of serious adverse events<br>Timepoints:During the 15 days<br>