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Clinical Trials/PER-062-20
PER-062-20Completed未知

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

Instituto Quimioterapico S.A.,0 sites292 target enrollmentStarted: November 30, 2020Last updated:
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Trial Snapshot

Phase
未知
Status
Completed
Enrollment
292
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

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.
  • •- Negative SARS COV-2 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.

Investigators

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