A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Guaifenesin (Drug)
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.
干预措施: Sulfamethoxazole (Drug)
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.
干预措施: Trimethoprim (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician
时间窗: From Day 1 up to end of observation (up to 10 days)
次要结局
- 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))