Assessment of CliniCal Efficacy and Safety of Azithromycin in PharyngiTis ACCEPT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of Patient achieving clinical cure (Clinical cure is defined as complete resolution of clinical sign & symptoms of pharyngitis)
研究概览
简要总结
This is a Retrospective, Observational, Real world evidence, data retrieval study planned with an objective “To evaluate the efficacy and safety of Azithromycin in patients who had received it in the past for the treatment of pharyngitisâ€. For evaluating efficacy, assessment of the severity and course of the disease were done by using clinical findings and symptoms of the pharyngitis. Severity of the disease will be classified into three groups:mild, moderate and severe. The data retrieval will be done from the ENT specialists using medical records of the patients.
For safety evaluation, the reported adverse events which resulted from concurrent illnesses, reactions to concurrent medications were analysed through retrieved medical record form.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged more than or equal to 18 years of either gender
- •Patients who had received oral Azithromycin for the management of pharyngitis in the past.
排除标准
- •Patients those who were not suitable to receive Azithromycin tablet in management of Pharyngitis as per the local prescription data.
结局指标
主要结局
Proportion of Patient achieving clinical cure (Clinical cure is defined as complete resolution of clinical sign & symptoms of pharyngitis)
时间窗: From baseline till 5th day after treatment initiation
次要结局
- Proportion of patients having treatment related side-effects on day 3 and day 5(Day 3 and Day 5 after treatment initiation)
研究者
Dr Dinesh Patil MBBS MD
Alembic Pharmaceuticals Limited