A Non-Interventional Safety Study of Balsamic Bactrim

November 3, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru, Lima 41
        • Clinica de Especialidades Medicas
      • Lima, Peru, 15088
        • Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias
      • Lima, Peru, Lima 41
        • Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH
      • San Juan de Miraflores, Peru, 15801
        • Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Interruption
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Discontinuation
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation
Time Frame: From Day 1 up to end of observation (up to 10 days)
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
Time Frame: From Day 1 up to end of observation (up to 10 days)
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)
Time Frame: From Day 1 up to end of observation (up to 10 days)
From Day 1 up to end of observation (up to 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML30018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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