Bronchitis
Conditions
Brief summary
This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.
Interventions
DRUGGuaifenesin
Guaifenesin will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
DRUGSulfamethoxazole
Sulfamethoxazole will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
DRUGTrimethoprim
Trimethoprim will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician | From Day 1 up to end of observation (up to 10 days) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change | From Day 1 up to end of observation (up to 10 days) |
| Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration | From Day 1 up to end of observation (up to 10 days) |
| Percentage of Participants With Balsamic Bactrim Dose Interruption | From Day 1 up to end of observation (up to 10 days) |
| Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) | From Day 1 up to end of observation (up to 10 days) |
| Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation | 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 | 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) | From Day 1 up to end of observation (up to 10 days) |
| Percentage of Participants With Balsamic Bactrim Treatment Discontinuation | From Day 1 up to end of observation (up to 10 days) |
Countries
Peru
Outcome results
None listed