Clinical Trial: An Observational Study to Assess Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult 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 Adult Patients With Acute Bronchitis

Brief Summary: This is a pilot, observational and multicentric study of safety of sulfamethoxazole plus (+) trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Overall, 50 adult participants with acute bronchitis eligible for treatment with sulfamethoxazole + trimethoprim + guaifenesin will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of participants with adverse events related to sulfamethoxazole + trimethoprim + guaifenesin (as assessed by the investigator) [ Time Frame: From baseline up to 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific pre-defined factors, these will be decided based on observations during study) [ Time Frame: From baseline up to 3 months ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: September 13, 2016
Date Started: November 14, 2016
Date Completion: June 24, 2017
Last Updated: May 16, 2017
Last Verified: May 2017