An observational study in Bronchitis, sponsored by Hoffmann-La Roche. Completed at 3 sites in Peru. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Hoffmann-La Roche · Observational
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.
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 51 is below the median of 446 across 70 observational studies indexed under Bronchitis.
Browse Bronchitis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label.
Exclusion Criteria:
Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label will be observed for safety.
Drug: Guaifenesin · Drug: Sulfamethoxazole · Drug: Trimethoprim
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician
Time frame: From Day 1 up to end of observation (up to 10 days)
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 Dose Interruption
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 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)
Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study)
Time frame: From Day 1 up to end of observation (up to 10 days)
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche