A Non-Interventional Safety Study of Balsamic Bactrim

  • Respiratory Disorder
Trial Status:


This trial runs in
  • San Borja
  • San Juan de Miraflores
  • San Miguel
Trial Identifier:

NCT02902640 ML30018

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      NCT02902640 , ML30018 Trial Identifier
      Guaifenesin, Sulfamethoxazole, Trimethoprim Treatments
      Bronchitis Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No 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

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