A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

  • Respiratory Disorder
Trial Status:


This trial runs in
  • Cercado de Lima
  • San Isidro
Trial Identifier:

NCT02879981 ML30017

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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 pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.

      Hoffmann-La Roche Sponsor
      NCT02879981 , ML30017 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 Pediatric Patients With Acute Bronchitis

      Eligibility Criteria

      All Gender
      ≥ 4 Years & ≤ 14 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participants starting treatment with Bactrim Balsamic suspension
      • Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria
      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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