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
NCT number | NCT02879981 |
Other study ID # | ML30017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 10, 2016 |
Est. completion date | August 28, 2017 |
Verified date | December 2019 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Peru,
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) |
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