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Completed

NCT Number: NCT02902640

A Non-Interventional Safety Study of Balsamic Bactrim

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.

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Key information

Conditions

Bronchitis Bronchial Diseases Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guaifenesin

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Percentage of Participants With Balsamic Bactrim Dose Interruption

    Time frame: From Day 1 up to end of observation (up to 10 days)

  5. Percentage of Participants With Balsamic Bactrim Treatment Discontinuation

    Time frame: From Day 1 up to end of observation (up to 10 days)

  6. Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation

    Time frame: From Day 1 up to end of observation (up to 10 days)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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