A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

Hoffmann-La Roche51 enrolled

Overview

This pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bronchitis

Interventions

GuaifenesinDRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

SulfamethoxazoleDRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

TrimethoprimDRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants starting treatment with Bactrim Balsamic suspension * Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria Exclusion Criteria: * Participants who have started treatment with another antibiotic at the time of the visit * Participants with no respiratory infections * Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria * Participants with severe hepatic parenchymal damage * Participants with severe renal failure making it difficult to monitor drug plasma concentration * Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas

Locations (3)

Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica

La Victoria, Peru

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Lima, Peru

Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA

San Isidro, Peru

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician