CTRI/2024/06/069427已完成Unknown
A Multicentre, Prospective Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of Clarithromycin 500 Mg ER In Upper Respiratory Tract Infection
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 6
- 主要终点
- To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating percentage of patients termed cured/ improved/ failure.
研究概览
简要总结
A Prospective, Multicenter, Open-Label, Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of Clarithromycin 500 Mg ER In Upper Respiratory Tract Infection approximately on 237 patients from approximately 6 clinical sites. There are two Onsite visits and one telephonic visit on 5th day after second visit in the study and study duration is of 7 days +/- 2 (Onsite visit) and 5th day after second visit (Telephonic visit) day window period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and female patients 18 to 65 years of age 2 Newly diagnosed patients with onset of symptoms in previous 7 days with acute URTI (acute bacterial sinusitis, acute pharyngotonsillitis or acute otitis media) in the designated clinics as part of routine clinical care 3 Patients prescribed to start clarithromycin 500 mg ER tablets once daily, as part of routine clinical practice 4 Patients willing and able to sign a patient authorisation form (PAF) prior to study participation.
排除标准
- •â€¢ Patients who had been diagnosed and treated for an acute infection within the previous 28 days of study enrolment.
- •â€¢ Patients who may require hospitalization or ventilator support for the present complaints.
- •â€¢ Patients with history of clarithromycin or other antibiotic use in the preceding 1 month of study enrolment.
- •â€¢ Patients diagnosed with LRTI as per Investigator discretion.
- •â€¢ Hypersensitivity to macrolides.
- •â€¢ Patients on concomitant medication like steroids or other antibiotics.
- •â€¢ Patients on any other contraindicated medication based on approved prescribing information.
- •â€¢ Patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including anti.
- •â€¢ Pregnant or lactating women.
- •â€¢ Patients with any other conditions or diseases that Investigator/ HCP considers as ineligible to enroll in the study based on approved prescribing information.
结局指标
主要结局
To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating percentage of patients termed cured/ improved/ failure.
时间窗: Day 7
次要结局
- To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating the percentage change in clinical symptoms scores.(Day 7)
研究者
Dr Samir Bhargava
Bhargava Nursing Home
研究点 (6)
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