CTRI/2017/11/010388已完成3 期
A Prospective, Double Blind, Randomized, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of PLENMOXI (Moxifloxacin Intravenous Infusion 0.4% w/v) of Unosource Pharma, India and AVELOX (Moxifloxacin 400mg /250 ml solution for infusion) in the Treatment of Bacterial Infections.
OSOURCE PHARMA LTD0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or female 18 years of age or older
- •Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)
- •Production of purulent sputum or change in the character of sputum consistent with bacterial infection
- •Difficulty in breathing
- •Chest pain due to pneumonia and have at least 3 of the following findings:
- •1.Fever (oral temperature greater than 38.0°C)
- •2.Hypothermia (oral temperature less than 35.0°C)
- •3.Tachycardia (heart rate more than 100 beats/min)
- •4.Tachypnea (respiratory rate more than 18 breaths/min)
- •Hypoxemia (oxygen saturation less than 90% or PaO2 less than 60 mmHg on room air or with subject baseline [pre-CABP under study] supplemental oxygen
- •Clinical evidence of pulmonary consolidation and/or presence of pulmonary rates
- •An elevated white blood cell count (WBC) greater than 10,000/ mm³ or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC less than 4500/mm³
排除标准
- •A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class
- •Any infection expected to require other systemic antibiotics in addition to study drug
- •Receipt of systemic antibiotic therapy in the 7 days before enrollment
- •One dose of a single potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment is allowed
- •Respiratory infection confirmed or suspected to be secondary to hospital-required or ventilator-associated pneumonia or requires treatment in an intensive care setting, or mechanical ventilation
- •Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
- •Known anatomical or pathological obstruction or history of bronchiectasis or GOLD Stage 4 COPD or history of post obstructive pneumonia
- •Severely compromised immune system
- •Other exclusions include those described in the safety label for drugs in the quinolone and /or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents
- •Subjects who are having positive serology
- •Pregnant and lactating women
研究者
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