NCT00315042终止3 期
Multinational, Randomized, Double-Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 10 Days Penicillin V 13.3 mg/kg Tid in Children 6 Months to Less Than 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 314
- 试验地点
- 6
- 主要终点
- To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V in subjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population
研究概览
简要总结
This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months to less than 13 years of age (<13);
- •Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:
- •A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and
- •A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:
- •Tonsil and/or pharyngeal erythema and/or exudate;
- •Cervical adenopathy;
- •Uvular edema;
排除标准
- •Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);
- •History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;
- •Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);
- •History of rheumatic heart disease;
- •Females of childbearing potential (ie, have reached menarche);
- •Known congenital prolonged QT syndrome;
- •Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm);
- •Myasthenia gravis;
- •Known impaired renal function, as shown by creatinine clearance ≤25 mL/min
- •The subject:
- •Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin;
- •Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days;
- •Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.
- •History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;
- •Previous enrollment in this study or previous treatment with telithromycin;
- •Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.
结局指标
主要结局
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V in subjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population
次要结局
- To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V in subjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population
研究者
研究点 (6)
Loading locations...
相似试验
终止
3 期
TELI COM - Telithromycin in Children With Otitis MediaOtitis Media, SuppurativeOtitis Media, PurulentNCT00315003Sanofi1,500
终止
3 期
TELI TAD - Telithromycin in Tonsillitis in Adolescents and AdultsTonsillitisPharyngitisNCT00315549Sanofi233
进行中（未招募）
1 期
A multinational, randomized, double-blind, double-dummy, exploratory, parallel-group, dose-ranging phase II study to evaluate the pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionated heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention. - The SEPIA-PCI TrialPatients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)EUCTR2004-000904-41-SKAventis Pharmaceuticals Inc.930
进行中（未招募）
1 期
A multinational, randomized, double-blind, double-dummy, exploratory, parallel-group, dose-ranging phase II study to evaluate the pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionated heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention. - The SEPIA-PCI TrialPatients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)EUCTR2004-000904-41-ESAventis Pharmaceuticals Inc.930
进行中（未招募）
不适用
A multinational, randomized, double-blind, double-dummy, exploratory, parallel-group, dose-ranging phase II study to evaluate the pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionated heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention. - The SEPIA-PCI TrialPatients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)EUCTR2004-000904-41-CZAventis Pharmaceuticals Inc.930