Bronchitis
Conditions
Brief summary
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.
Interventions
DRUGGuaifenesin
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
DRUGSulfamethoxazole
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
DRUGTrimethoprim
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by 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 (Increase or Decrease) | From Day 1 up to end of observation (up to 10 days) |
| 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 Predisposing Factors (Categories) for Safety (No specific predefined 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) |
| 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 Balsamic Bactrim Dose Interruption | From Day 1 up to end of observation (up to 10 days) |
Countries
Peru
Outcome results
None listed