A Non-Interventional Safety Study of Balsamic Bactrim

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT02902640

Collaborator

(none)

Enrollment

Locations

8.5

Actual Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchitis	Drug: Guaifenesin Drug: Sulfamethoxazole Drug: Trimethoprim

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 15, 2016

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Acute Bronchitis Participants 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 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. Drug: 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. Drug: 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.

Arm

Intervention/Treatment

Acute Bronchitis Participants

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

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.

Drug: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias	Lima	Peru	15088
2	Clinica de Especialidades Medicas	Lima	Peru	Lima 41
3	Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH	Lima	Peru	Lima 41
4	Centro de Investigaciones Medicas/Hospital Maria Auxiliadora	San Juan de Miraflores	Peru	15801