EUCTR2007-001735-66-EE进行中（未招募）不适用
A double blind, multicentre, multinational, randomized, double dummy, three-arm parallel-group comparative study of the efficacy, safety and tolerance of oral NXL103 (500 mg twice daily) versus NXL103 (600 mg twice daily) versus oral amoxicillin (1000 mg three times daily) in the treatment of community-acquired pneumonia in adults
ovexel S. A.0 个研究点目标入组 300 人开始时间: 2007年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Only patients with mild to moderately severe (The inclusion and exclusion criteria are built in such a way to include only subjects with CURB-65 score 0 or 1 see Appendix I) pneumonia will be included in this study.
- •Informed consent must be obtained for all subjects before enrollment in the study.
- •Subjects meeting all of the following criteria will be considered for admission to the study:
- •Adult male subjects aged 18 to 70 years, Female subjects who have been postmenopausal for at least 1 year or is surgically incapable of bearing children.
- •Subjects with diagnosis of acute CAP based upon:
- •? new onset of at least two of the following clinical signs and symptoms:
- •production of purulent or rusty sputum
- •auscultatory findings [such as rales, pleural rubs and/or evidence of pulmonary consolidation (i.e., dullness on percussion, bronchial breath sounds, egophony)]
- •dyspnea or tachypnea (particularly if progressive in nature) or pleuritic chest pain
- •? and at least one of the following:
- •fever (oral temperature > 38oC or tympanic temperature > 38.5oC or rectal temp. > 39oC)
- •elevated total peripheral white blood cell count >10,000/mm3 or > 15? band forms, regardless of total peripheral white count
- •? chest x-ray findings which support a clinical diagnosis of bacterial pneumonia (e.g. presence of presumably new infiltrate(s) or lobar consolidation or segmental consolidation).
- •Hospitalized (for study purpose or as is the local practice) or out-patients
- •Subjects should have specimens collected for bacteriological documentation within 24 hours prior to enrollment. Specimens should include:
- •? respiratory/sputum samples for Gram stain, cultures, susceptibility testing.
- •? blood samples for culture.
- •Note: Subjects will be enrolled based upon investigator assessment of x-ray, after obtaining a report from a qualified radiologist. Subjects will be enrolled before the bacteriological results are available.
- •No patient is allowed to enter this study more than once.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with severe CAP, defined as those requiring either intensive care unit (ICU) admission, parenteral antibiotic treatment, or demonstrating at least one of the following conditions:
- •? respiratory frequency > 30 breaths/minute
- •? chest radiograph showing bilateral involvement or involvement of multiple lobes
- •? shock (systolic blood pressure < 90 mm Hg or diastolic blood pressure = 60 mm Hg)
- •? altered mental status (disorientation to person, place, or time that is not known to be chronic, lethargy, stupor, or coma)
- •? < 90% O2 saturation (by pulse oximetry) or a PaO2 < 60 mm Hg
- •? total peripheral white blood cell count < 4,000/mm3
- •? requirement for mechanical ventilation
- •? requirement for vasopressors for more than 4 hours
- •? urine output lower than 20 mL/h or total urine output lower than 80 mL in 4 hours, unless another explanation is available, or acute renal failure requiring dialysis
- •? blood urea > 7mmol/L
- •Subjects with respiratory tract infections attributable to sources other than community-acquired bacterial infection
- •Subjects with any concomitant pulmonary disease, condition or complications that could confound the interpretation or evaluation of drug efficacy or safety
- •Subjects with neoplastic lung disease (lung cancer) or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic interventions for this or other neoplasms.
- •Subjects who are receiving other medications, including other systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or drug safety.
- •Subjects who have received more than 24 hours of treatment with other antibiotics, within the 7 days prior to enrollment in the study.
- •Subjects treated within the 7 days prior to enrollment with azithromycin or dirithromycin, ceftriaxone, quinolones, amoxicillin and amoxicillin/clavulanic acid.
- •Subjects with a microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications.
- •Subjects with known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to the study medication, macrolide antibiotics, or ß-lactam antibiotics.
- •Subjects receiving probenecid treatment.
- •Subjects who will require on-study treatment with medications known to have contraindicated drug interactions with the study medication and/or macrolides in general, including but not limited to:
- •? Ergot alkaloids derivatives, terfenadine, cisapride, astemizole, pimozide, cholinesterase inhibitors (e.g., tacrine, donepezil, physostigmine), ketamine, cardiac glycosides (e.g., digoxin), St. John’s Wort, ketoconazole, itraconazole, quinidine, and disopyramide
- •Subjects with known long QTc syndrome, sick sinus syndrome, bradycardia (heart rate of < 50 beats/minute), or severe hypokalemia.
- •Subjects who have received any investigational drug within 1 month prior to study entry or such treatment is planned for during the study period.
- •Subjects with progressively fatal disease; life expectancy ? 3 months.
- •Subjects with any concomitant condition, including clinically relevant cardiovascular, neurologic, endocrine, or other major systemic disease that make implementation of the protocol or interpretation of the study results difficult.
- •Subjects with a recent (within previous 3 months) history of drug or alcohol abuse.
- •Subjects with impaired hepatic function, as shown by any of the following:
- •? ALAT and/or AS
研究者
相似试验
进行中（未招募）
不适用
A double blind, multicentre, multinational, randomized, double dummy, three-arm parallel-group comparative study of the efficacy, safety and tolerance of oral NXL103 (500 mg twice daily) versus NXL103 (600 mg twice daily) versus oral amoxicillin (1000 mg three times daily) in the treatment of community-acquired pneumonia in adultsCommunity-Acquired PneumoniaEUCTR2007-001735-66-DEovexel S. A.300
已完成
不适用
A multicentre, multinational, double blind, randomised, parallel group, placebo-controlled study of ethyl-eicosapentaenoate (EPA) in patients with Huntington's disease (HD)Huntington's diseaseNervous System DiseasesISRCTN79170611axdale Ltd (UK)
进行中（未招募）
不适用
A double-blind, multi-center, multinational, randomized withdrawal study evaluating the efficacy and safety of SR58611A (350 mg q12) versus placebo in the prevention of depression relapse up to 1 year in patients with Major Depressive Disorder improved after 12 weeks of open treatment with SR58611A (350 mg q12) - CALYPSOpatients with major depressive disorderMedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-004006-81-FIsanofi-aventis recherche & développement800
进行中（未招募）
不适用
A multicentre, multinational, double-blind, randomised, parallel group, placebo controlled trial of ethyl-EPA ethyl-Icosapent in patients with Huntington s Disease - NDEUCTR2005-002088-98-ITAMARIN NEUROSCIENCE LTD240
进行中（未招募）
不适用
A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4)EUCTR2015-000395-97-Outside-EU/EEAGilead Sciences, Inc.157