A Non-Interventional Safety Study of Balsamic Bactrim

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02902640
• Date of registration: 13/09/2016
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Non-Interventional Safety Study of Balsamic Bactrim
• Scientific title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Patients With Acute Bronchitis
• Date of first enrolment: November 15, 2016
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02902640
• Study type: Observational
• Phase: N/A

Countries of recruitment

Peru

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants starting treatment with Balsamic Bactrim as per treating physician's
discretion

- Participants with a clinical diagnosis of acute bronchitis (cough with or without
sputum production less than 30 days) according to the treating physician's judgment

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bronchitis

Intervention(s)

Drug: Trimethoprim

Drug: Sulfamethoxazole

Drug: Guaifenesin

Primary Outcome(s)

Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Secondary Outcome(s)

Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [Time Frame: From Day 1 up to end of observation (up to 10 days)]

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 Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Balsamic Bactrim Dose Interruption [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [Time Frame: From Day 1 up to end of observation (up to 10 days)]

Secondary ID(s)

ML30018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors