PER-066-07已完成未知
DOUBLE-BLIND, MULTICENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-SIMULATED, THREE-PARALLEL GROUP, STUDY INTENDED TO COMPARE THE EFFICACY, SAFETY AND TOLERANCE OF NXL103 ADMINISTERED BY ORAL ROUTE (500 MG TWICE A DAY) IN FRONT OF NXL103 ADMINISTERED BY ROAD ORAL (600 MG TWICE A DAY) AGAINST ORAL AMOXICILLIN (1000 MG THREE TIMES A DAY) IN THE TREATMENT OF PNEUMONIA ACQUIRED IN THE COMMUNITY IN ADULTS
OVEXEL S.A.,0 个研究点目标入组 0 人开始时间: 2007年12月27日最近更新:
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
- •Only patients with mild to moderately severe pneumonia will be included in this study (the inclusion and exclusion criteria are designed to include only subjects with pneumonia with a CURB-65 score of 0 or 1).
- •Informed consent of all subjects must be obtained prior to enrolling in the study.
- •Adult male subjects between 18 and 70 years of age, female subjects have been postmenopausal for at least 1 year or are surgically unable to procreate.
- •Subjects with acute NAC diagnosis
- •Hospitalized (for study purposes or as local practice) or outpatients
- •Subjects to whom samples must be taken for bacteriological documentation within 24 hours prior to enrollment.
排除标准
- •Subjects with severe NAC, defined as those requiring either hospitalization in an intensive care unit (ICU), parenteral antibiotic treatment
- •Subjects with respiratory tract infections attributable to a source other than bacterial infections acquired in the community
- •Subjects with any pulmonary disease, condition or concomitant complications that may confuse the interpretation or evaluation of the efficacy or safety of the drug
- •Subjects with neoplastic lung disease (lung cancer) or other malignancy with pulmonary metastases, and / or requirement for chemotherapeutic intervention for these or other neoplasms.
- •Subjects who are receiving other medications, including other systemic antimicrobial agents, or who have other disease conditions or infections that may interfere with the evaluation of the efficacy or safety of the drug.
- •Subjects who have received treatment with other antibiotics for more than 24 hours in the 7 days prior to enrollment in the study.
- •Subjects treated with azithromycin or dirithromycin, ceftriaxone, quinolones, amoxicillin and amoxicillin / clavulanic acid in the 7 days prior to enrollment.
- •Subjects with a microbiologically documented infection with a pathogen known to be resistant to study medication before inclusion in it.
- •Subjects with known or suspected hypersensitivity, or a serious adverse reaction known or suspected to the study medication, to macrolide antibiotics or to b-lactam antibiotics.
- •Subjects receiving treatment with probenecid.
- •Subjects who are going to need during the treatment of the study drugs that are known to have interactions with drugs contraindicated with the study medication and / or the macrolides in general
- •Subjects with prolonged QTc syndrome, confirmed, sick sinus syndrome, bradycardia (heart rate <50 beats / minute), or severe hypokalemia.
- •Subjects who have received any investigational drug in the month prior to entering the study or who have scheduled that type of treatment during the study period.
- •Subjects with a fatal progressive disease; Life expectancy <3 months.
- •Subjects with any concomitant condition, including cardiovascular, neurological, clinically relevant endocrine, or other important systemic disease that may hinder the implementation of the protocol or the interpretation of the study results.
- •Subjects with a recent history (within the previous 3 months) of drug or alcohol abuse.
- •Subjects with impaired hepatic function
- •Subjects with altered renal function, observed by a creatinine clearance <50 mL / min (creatinine clearance can be estimated with the formula).
- •Pregnant or lactating woman.
- •Immunocompromised subjects
- •Subjects with a mental condition that makes the subject unable to understand the nature, scope and possible consequences of the study.
- •Subject who can not comply with the protocol (eg, non-cooperative attitude, inability to return to follow-up visits, and improbability of completing the study).
研究者
相似试验
已完成
不适用
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes-E669 Obesity, unspecifiedObesity, unspecifiedE669PER-053-08sanofi-aventis Recherche & Development,
已完成
不适用
MULTINATIONAL, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY, IN PARALLEL GROUPS, TO EVALUATE THE EFFICACY OF ZOLEDRONIC ACID ADMINSTRATED BY INTRAVENOUS VIA IN THE PREVENTION OF OSTEOPOROTIC FRACTURES AFTER A HIP FRACTURE.-S729S729PER-061-02OVARTIS BIOSCIENSES PERU S.A.,
进行中（未招募）
不适用
Randomized, multinational, multicentre, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors. - CRESCENDOEUCTR2005-002942-20-IESanofi-Synthelabo Recherche17,000
尚未招募
3 期
Randomized, Multicenter, Multinational, Double-Blind Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV Non-Squamous Non-Small Cell Lung CancerB47 MycetomaMycetomaPER-010-23aboratorio Elea Phoenix S.A.
进行中（未招募）
不适用
Randomized, multinational, multicenter, double-blind, placebo-controlled, two-armparallel group trial of rimonabant 20 mg OD for reducing the risk of majorcardiovascular events in abdominally obese patients with clustering risk factors - CRESCENDOPatients with abdominal obesity at increased risk for cardiovascular events (myocardial infarctio, stroke and cardiovascular death)MedDRA version: 8.0Level: LLTClassification code 10051615EUCTR2005-002942-20-ATSanofi-Synthelabo Recherche17,000