COMPARATIVE, RANDOMISED, OPEN LABEL, PARALLEL, MULTICENTRIC STUDY, EFFICACY AND SAFETY OF ORAL GARENOXACIN VS LEVOFLOXACIN IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment
研究概览
简要总结
This is a Comparative, Randomised, Open-label, Parallel, Multicentric study of efficacy and safety of oral Garenoxacin versus Levofloxacin in patients with Community Aquired Pneumonia. 2. The proposed number of subject to be enrolled in to the study is 250 (this number includes the expected no. of dropouts) and data will be submitted 200 completed patients. Study population will comprise of Patients with Community Aquired Pneumonia. 3. The recommended dose of Garenoxacin in dose of 2x200mg in comparison with Levofloxacin in dose of 500mg once daily for 7/10 days. 4. The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient’s atleast 18 years of age with Community Acquired Pneumonia. (Acute bronchitis, acute exacerbation of chronic bronchitis, Community Acquired pneumonia).
- •Clinical signs and symptoms consistent with Community Acquired Pneumonia suspected of being caused by bacteria susceptible to Garenoxacin and where investigator deemed oral Garenoxacin to be appropriate therapy by clinical suspicion with or without positive culture results.
- •Clinical diagnosis.
- •Patient should have atleast two of the following signs and symptoms: a. Cough b. Production of purulent sputum or change in character of sputum c. Auscultator findings of rales and / or evidence of consolidation (dullness of percussion, bronchial breath sounds or egophony) d. Fever defined as oral temperature 380C e. Dyspnoea or tacypnoea f. Total WBC count 10,000 /cumm
- •Radiological diagnosis.
- •Chest radiograph showing the presence of a new alveolar or patchy infiltrates suggestive of acute pneumonia
- •Microbiological diagnosis.
- •Gram stain examination of sputum specimen showing presence of micro-organisms, squamous epithelial cells and polymorph nuclear cells
- •Biochemistry, haematology, and urine analysis test results without clinically significant abnormalities.
- •Patients willing to give informed written consent.
排除标准
- •Pregnant and lactating women.
- •Patients with clinically significant renal or hepatic disease.
- •Patients who have shown immediate hypersensitivity reactions to the quinolone class of antibiotics.
- •Patients with bronchialasthma,bronchiectasis, cystic fibrosis, and lung abscess, AIDS, Pneumocystis caranii pneumonia, pulmonary tuberculosis, primary or secondary lung malignancy.
- •Patients with extensive bilateral consolidation and pleural effusion.
- •Patients with severe neurological or cardiovascular disease and uncontrolled diabetes mellitus
- •History of having received any investigation drugs in previous one month or has donated blood in last 3 months.
- •Patients with abnormal lab values (2 times of upper limit of normal).
- •Non co-operative attitude of the patient.
- •Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion for the study.
- •Patients with any condition or concomitant infection, which in the opinion of the investigator could preclude evaluation of response to study medication.
结局指标
主要结局
The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment
时间窗: 0, 4, 7/10 days
次要结局
- The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study(0, 4, 7/10 days)