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

Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879981
• Other study ID #: ML30017
• Status: Completed
• Start date: November 10, 2016
• Est. completion date: August 28, 2017

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis

Intervention

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

Locations

Country	Name	City	State
Peru	Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica	La Victoria
Peru	Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional	Lima
Peru	Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA	San Isidro

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Dose Interruption		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Treatment Discontinuation		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician		From Day 1 up to end of observation (up to 10 days)
Secondary	Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study)		From Day 1 up to end of observation (up to 10 days)