A Non-Interventional Safety Study of Balsamic Bactrim

Completed

• Conditions: Bronchitis
• Interventions: Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim

• Registration Number: NCT02902640
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Study Start: 2016-11-15
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Bronchitis Participants	Guaifenesin	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.
Acute Bronchitis Participants	Sulfamethoxazole	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.
Acute Bronchitis Participants	Trimethoprim	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 Treatment Discontinuation	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)

Trial Locations

Locations (4)

Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH; 🇵🇪 Lima, Peru

Clinica de Especialidades Medicas; 🇵🇪 Lima, Peru

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora; 🇵🇪 San Juan de Miraflores, Peru

Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias; 🇵🇪 Lima, Peru