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

• Status: Completed
• Trial end date: 2017-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Chlorpheniramine, phenylpropanolamine drug combination; Guaifenesin; Phenylpropanolamine; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

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