PER-037-01已完成未知
A RANDOMIZED, DOUBLE-BLIND, COMPARATIVE MULTICENTER STUDY IN PHASE III WITH BMS-284756INTRAVENOUS FOLLOWED BY BMS-284756 ORAL AGAINST INTRAVENOUS CEFTRIAXONE FOLLOWED BY ORAL CLARITHROMYCIN IN THE TREATMENT OF PNEUMONIA ACQUIRED IN THE COMMUNITY
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2001年7月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Patients recently hospitalized (that is, less than 24 hours), male or female, 18 years of age or older, with clinical evidence of moderate to severe community-acquired pneumonia, demonstrated by the following:
- •1) A new infiltrate in the chest X-ray;
- •2) Two or more of the following findings:
- •a) Fever (> 38 ° C or 100.4 ° F orally, <38.5 ° C or> 102.1 ° F taken by the eardrum, or> 39 ° C or> 102.2 ° F taken rectally),
- •b) Leukocytosis (> 10,000 white blood cells / mm ^ or> 15 abashed),
- •d) Pleuritic pain,
- •e) Auscultatory findings such as rales and / or evidence of pulmonary consolidation (eg, egophony, bronchial breath sounds, or dullness in percussion),
- •g) Sputum production (if sputum is produced, a sample should be sent to the laboratory for Gram stain and culture for aerobic germs).
- •Written informed consent of the subject or an authorized legal representative
- •Women with child-bearing potential (WOCBP) should have a serum or urine test to detect pregnancy (minimum sensitivity, 25 International Units / L or its equivalent in HCG units) within the 48 hours before starting the medication under study.
排除标准
- •Subjects who have received more than one dose of any systemic antibiotic (or more than one dose of a combination of antibiotics, such as a cephalosporin plus a macrolide) within a period of 7 days prior to recruitment, or who are likely to receive other systemic antibiotics during your participation in the study; subjects receiving a systemic antifungal or antiviral agent for prophylaxis are eligible to enter the study and may continue with such medications
- •Subjects who, in the opinion of the investigator, may require long-term antibacterial therapy (for example, for more than 14 days)
- •Subjects with a terminal illness (defined as the subjects who will expire within the next 72 hours) or with a rapidly progressive underlying disease; which, in the opinion of the researcher, prevented the evaluation of the response to therapy
- •Previously diagnosed conditions that tend to resemble or complicate the course and evaluation of the infectious process (for example, a known bronchial obstruction apart from asthma or chronic obstructive pulmonary disease [COPD], history, of post-obstructive pneumonia, cystic fibrosis, malignancy active lung)
- •Active tuberculosis or suspicion of such condition, or any lung infection with other mycobacteria, fungi, parasites or viruses (patients with bacterial pneumonia after infection with influenza or other respiratory viruses are eligible)
- •Documentation or suspicion of Pneumocystis carini pneumonia
- •Diseases previously diagnosed of the immune function. (for example, AIDS, current neutrophil count <1000 / mm3)
- •Documented current and clinically significant liver disease or documented values of ALT and / or AST and / or total bilirubin> 3 times the upper limit of normal;
- •Subjects on chronic treatment (eg, ^ week) with systemic steroids at a dose> 10 mg / day of prednisone (or its equivalent) or some other chronic immunosuppressive therapy
- •Documented renal insufficiency (eg, serum creatinine> 2.0 mg / dL (176.7 umol / L) or dialysis requirement)
- •Subjects with empyema
- •Subjects with a primary lung abscess
- •Infection acquired in the hospital or hospitalization for any reason within the previous 14 days [excluding the 24-hour period prior to recruitment]
- •History of any serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone, beta-lactam or macrolide;
- •Malabsorption syndromes or other gastrointestinal disturbances that affect the absorption of drugs
- •Concomitant use of an agent in research or in the 30 days prior to entering the study
- •Pre-recruitment in any study with BMS-284756
- •Pregnancy and / or being breastfeeding
- •Any disorder or illness that could interfere with the evaluation of the drug under study and / or that in the opinion of the investigator made the subject unsuitable for recruitment;
- •Subjects under treatment with terfenadine, cisapride or astemizole.
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