A Non-Interventional Safety Study of Balsamic Bactrim

Roche

Status: Completed

Conditions: Bronchitis

Treatments: Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim

Study type: Observational

Funder types: Industry

Identifiers

NCT02902640

ML30018

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Acute Bronchitis Participants

Description:

Participants with acute bronchitis for whom the treating physician has decided to initiate treatment with Balsamic Bactrim, will be observed. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling. The study protocol does not enforce any treatment.

Treatment:

Drug: Trimethoprim

Drug: Guaifenesin

Drug: Sulfamethoxazole