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

Completed

• Conditions: Bronchitis
• Interventions: Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim

• Registration Number: NCT02879981
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Study Start: 2016-11-10
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Participants With Acute Bronchitis	Trimethoprim	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.
Pediatric Participants With Acute Bronchitis	Guaifenesin	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.
Pediatric Participants With Acute Bronchitis	Sulfamethoxazole	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change	From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration	From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Interruption	From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)	From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation	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	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)	From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Discontinuation	From Day 1 up to end of observation (up to 10 days)

Trial Locations

Locations (3)

Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica; 🇵🇪 La Victoria, Peru

Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA; 🇵🇪 San Isidro, Peru

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional; 🇵🇪 Lima, Peru