Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 502
- 主要终点
- Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
研究概览
简要总结
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
详细描述
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral.
- •Subjects must have no prior experience with Azithromycin SR.
排除标准
- •Patients not administered Azithromycin SR.
研究组 & 干预措施
Azithromycin SR
Patients taking Azithromycin.
干预措施: Azithromycin SR (Drug)
结局指标
主要结局
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
时间窗: Baseline to 29 days
The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.
Number of Participants With Treatment Related Adverse Events (TRAEs)
时间窗: Baseline to 29 days
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Unlisted Treatment Related Adverse Events (TRAEs)
时间窗: Baseline to 29 days
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
次要结局
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)(Baseline to 29 days)
- Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy(Baseline to 29 days)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female(Baseline to 29 days)