CTRI/2019/11/021964已完成3 期
A Phase III, Randomised, Multicentre, Double-Blind, Comparative Study to Determine the Efficacy and Safety of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 19
- 主要终点
- To demonstrate that oral nafithromycin is non-inferior to oral moxifloxacin in the clinical response at Day 4 in the Modified Intent to Treat (MITT) analysis set
研究概览
简要总结
This is a Phase III, prospective, multicentre,randomised, double-blind, comparative efficacy and safety study of oralnafithromycin versus oral moxifloxacin for the treatment of male and femaleadults with CABP. Subjects providing informed consent and meeting all studyeligibility criteria will be enrolled in the study and randomised in a 1:1ratio to either of the following 2 treatment arms
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Meet the following clinical criteria for CABP: Have at least TWO of the following symptoms (new or worsening): Dyspnoea (shortness of breath) Cough Production of purulent sputum Pleuritic chest pain Have at least TWO of the following vital sign abnormalities: Fever or hypothermia documented by the Investigator (oral, rectal or tympanic temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F]) Hypotension, defined as systolic blood pressure < 90 mmHg Tachycardia, defined as heart rate > 90 beats per minute Tachypnoea, defined as respiratory rate > 20 breaths per minute Have at least ONE of the following clinical signs or laboratory abnormalities: Hypoxaemia defined as arterial oxygen saturation < 90% by pulse oximetry or partial pressure of arterial oxygen < 60 mmHg by arterial blood gas Auscultatory findings on pulmonary examination consistent with bacterial pneumonia or pulmonary consolidation (e.g. rales, dullness on percussion, bronchial breath sounds or egophony) Elevated total white blood cell (WBC) count (> 10,000 cells/mm3) or leucopenia (WBC < 4000 cells/mm3) Elevated immature neutrophils (> 15% band forms), regardless of total peripheral WBC count dRadiographic evidence of CABP: Radiographically confirmed pneumonia, i.e., new or progressive pulmonary infiltrate(s) on chest X-ray or chest computed tomography scan consistent with acute bacterial pneumonia within 48 h before randomisation PORT score of 51 to 105 (PORT Risk Class of II, III or IV) All females must have a negative urine or serum pregnancy test (beta human chorionic gonadotropin) at Screening AND agree to the use of 1 of the following acceptable methods of contraception from Screening through TOC All males must agree to use an acceptable barrier method of birth control.
排除标准
- •Subjects with any of the following confirmed or suspected types of pneumonia: Aspiration pneumonia Hospital-acquired bacterial pneumonia, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h hospitalisation in an acute inpatient healthcare facility Healthcare-associated bacterial pneumonia, defined as pneumonia acquired in a long-term care or subacute healthcare facility (e.g. nursing home) or pneumonia with onset after recent hospital discharge (within 90 days of current admission and previously hospitalised for ≥ 48 h) Ventilator-associated bacterial pneumonia, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h of endotracheal intubation Pneumonia that may be caused by pathogen(s) resistant to any study drug (nafithromycin, moxifloxacin), including viral, mycobacterial or fungal pneumonia (e.g. Pneumocystis jiroveci pneumonia, active pulmonary tuberculosis) Post-obstructive pneumonia Pneumonia associated with cystic fibrosis, bronchiectasis or any other chronic pulmonary disease Suspected or confirmed pleural empyema (a parapneumonic pleural effusion is not an exclusion criterion) or lung abscess Suspected or confirmed non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure) Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP within 72 h before randomisation except if the prior therapy is a single dose of a short-acting antibacterial agent ; subjects requiring concomitant adjunctive or additional potentially effective systemic antibacterial treatment for management of CABP Evidence of significant immunologic disease.
结局指标
主要结局
To demonstrate that oral nafithromycin is non-inferior to oral moxifloxacin in the clinical response at Day 4 in the Modified Intent to Treat (MITT) analysis set
时间窗: EOT -Day 7; TOC-Day 15 ;FU-Day 31
•To assess overall safety of oral nafithromycin in the safety analysis set
时间窗: EOT -Day 7; TOC-Day 15 ;FU-Day 31
次要结局
- Clinical Response Assessment & Clinical Outcome Assessment(Day 4, TOC, EOT)
研究者
研究点 (19)
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