NCT02879981

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

A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bronchitis

Interventions

Type	Name	Description
DRUG	Guaifenesin	Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
DRUG	Sulfamethoxazole	Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
DRUG	Trimethoprim	Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Timeline

• Start date: 2016-11-10
• Primary completion: 2017-08-28
• Completion: 2017-08-28
• First posted: 2016-08-26
• Last updated: 2019-12-13

Locations

3 sites across 1 country: Peru