A Non-Interventional Safety Study of Balsamic Bactrim

Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902640
• Other study ID #: ML30018
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: November 3, 2017
• Start date: November 15, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis

Intervention

Drug:
• Guaifenesin
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.
• Sulfamethoxazole
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.
• Trimethoprim
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.

Locations

Country	Name	City	State
Peru	Clinica de Especialidades Medicas	Lima
Peru	Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias	Lima
Peru	Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH	Lima
Peru	Centro de Investigaciones Medicas/Hospital Maria Auxiliadora	San Juan de Miraflores

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Dose Interruption		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Treatment Discontinuation		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation		From Day 1 up to end of observation (up to 10 days)
Secondary	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)
Secondary	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)