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

NCT02879981

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Bronchitis

Interventions: Guaifenesin, Sulfamethoxazole, Trimethoprim

Countries: Peru

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.

Eligibility overview

Sex: ALL

Age: 4 Years to 14 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (3)
  • La Victoria, Peru
  • Lima, Peru
  • San Isidro, Peru