A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 337
- 试验地点
- 16
- 主要终点
- Average Time From Baseline to Recovery From Fever and Other Symptoms
研究概览
简要总结
Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.
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
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lower respiratory tract infection.
- •Patient is male or female > 6 months and < 12 years of age.
- •Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
- •Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information
排除标准
- •Known hypersensitivity to or previously intolerant of macrolides.
- •Illness severe enough to warrant hospitalization or parenteral therapy.
- •Concomitant use of any of the following medications:
- •Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
- •Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
- •Colchicine
- •Ritonavir.
- •Severe immunodeficiency and chronic disease conditions.
- •Renal or hepatic impairment.
研究组 & 干预措施
Children with lower respiratory tract infection
Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension
干预措施: clarithromycin (Klacid) granules for oral suspension (Drug)
结局指标
主要结局
Average Time From Baseline to Recovery From Fever and Other Symptoms
时间窗: Baseline to 14 days
Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.
次要结局
- Number and Type of Adverse Events(Baseline to 14 days)