A Non-Interventional Safety Study of Balsamic Bactrim

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult 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 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

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Acute Bronchitis Participants<br>Participants with acute bronchitis for whom the treating physician has decided to initiate treatment with Balsamic Bactrim, will be observed. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling. The study protocol does not enforce any treatment. | Drug: Guaifenesin<br>* 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.<br>Drug: Sulfamethoxazole<br>* 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.<br>Drug: Trimethoprim<br>* 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.<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 the 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 pre-defined factors, these will be decided based on observations during study) |  | From Day 1 up to end of observation (up to 10 days) |