Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 335
- 试验地点
- 12
- 主要终点
- Percentage of Participants With a Fast Recovery
研究概览
简要总结
The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, equal to or more than 18 years years of age
- •Patients with respiratory tract infections, including any of the following:
- •Acute tracheitis, acute tracheobronchitis
- •Acute sinusitis
- •Chronic sinusitis
- •Acute tonsillopharyngitis
- •Acute bronchitis
- •Mild community-acquired pneumonia
- •Acute exacerbation of chronic bronchitis
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, Digoxin, Some antiretrovirals: zidovudine and ritonavir.
- •Severe immunodeficiency and chronic disease conditions.
- •Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
- •Mental condition rendering the subject unable to understand the nature of the study.
研究组 & 干预措施
Clarithromycin modified release
Patients with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
干预措施: clarithromycin modified release 500 mg (Drug)
结局指标
主要结局
Percentage of Participants With a Fast Recovery
时间窗: Day 1 to Day 5
Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment. Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.
Percentage of Participants With Clinical Success
时间窗: 10 days
Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.
Classification of Overall Response
时间窗: 10 days
Based on the participant and physician's assessment, overall symptom response was classified as follows: * Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment. * Slow Responders: participants showing clinical recovery between Day 6 \& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms). * Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).
次要结局
- Percentage of Participants With Treatment Failure(10 days)
- Factors Affecting the Speed of Recovery(10 days)
- Number of Participants With Adverse Events(10 days)
- Fever Status at End of Study(10 days)
- Cough Status at End of Study(10 days)
- Sputum Status at End of Study(10 days)
- Dyspnea Status at End of Study(10 days)
- Abnormal Breathing Sounds Status at End of Study(10 days)
- Rhinorrhea Status at End of Study(10 days)
- Post-nasal Discharge Status at End of Study(10 days)
- Percentage of Participants Compliant With Treatment(10 days)