A Non-Interventional Safety Study of Balsamic Bactrim

Hoffmann-La Roche52 enrolled

Overview

This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bronchitis

Interventions

GuaifenesinDRUG

Guaifenesin will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.

SulfamethoxazoleDRUG

Sulfamethoxazole will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.

TrimethoprimDRUG

Trimethoprim will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants starting treatment with Balsamic Bactrim as per treating physician's discretion * Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the treating physician's judgment 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 (4)

Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias

Lima, Peru

Clinica de Especialidades Medicas

Lima, Peru

Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH

Lima, Peru

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

San Juán de Miraflores, Peru

Outcomes

Primary Outcomes

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