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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02879981
First Posted: August 26, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Bronchitis Drug: Guaifenesin Drug: Sulfamethoxazole Drug: Trimethoprim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: 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) ]
  • Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: 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) ]
  • 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) ]

Enrollment: 51
Actual Study Start Date: November 10, 2016
Study Completion Date: August 28, 2017
Primary Completion Date: August 28, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric Participants With Acute Bronchitis
Pediatric 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 will be observed for safety.
Drug: Guaifenesin
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Drug: Sulfamethoxazole
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Drug: Trimethoprim
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric 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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879981


Locations
Peru
Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica
La Victoria, Peru, 15033
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Peru, Lima 41
Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA
San Isidro, Peru, 27
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02879981     History of Changes
Other Study ID Numbers: ML30017
First Submitted: August 23, 2016
First Posted: August 26, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists