A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis

Conditions
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Bronchitis

Intervention / Treatment
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* Drug: Guaifenesin
* Drug: Sulfamethoxazole
* Drug: Trimethoprim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Participants With Acute Bronchitis<br>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<br>* Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.<br>Drug: Sulfamethoxazole<br>* Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.<br>Drug: Trimethoprim<br>* Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 Balsamic Bactrim Dose Interruption |  | 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 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) |