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NCT Number: NCT02879981

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

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.

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Key information

Conditions

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

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica, La Victoria, 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 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

Treatment and study plan

Guaifenesin

Drug

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Sulfamethoxazole

Drug

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Trimethoprim

Drug

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Primary outcomes

  1. Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by 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 predefined 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 Pediatric Patients With Acute Bronchitis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2016
Registry last updated
Dec 13, 2019

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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