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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: This pilot, multicentric and observational study will assess the of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to physician's recommendation under local labeling.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Participants With Related Adverse Events to Sulfamethoxazole + Trimethoprim + Guaifenesin as Assessed by Physician [ Time Frame: Baseline up to 5 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants With Compliance to Prescribed Dosage Regimen, As Assessed by Physician in Accordance With Local Clinical Practice and Local Labeling [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Change in Dose (Increase or Decrease) of Balsamic Bactrim [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Reason for Change in Dose (Increase or Decrease) of Balsamic Bactrim [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Change in Frequency of Balsamic Bactrim Dosing [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study) [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruptions [ Time Frame: Baseline up to 5 Months ]
  • Percentage of Participants With Balsamic Bactrim Dose Reintroduction [ Time Frame: Baseline up to 5 Months ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: August 23, 2016
Date Started: November 10, 2016
Date Completion: June 24, 2017
Last Updated: March 8, 2017
Last Verified: March 2017