EUCTR2014-004630-26-Outside-EU/EEA进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 760
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
- •Patients between 6 months to less than 13 years of age with the following inclusion criteria participated:
- •clinical diagnosis of acute tonsillitis/pharyngitis caused by S. pyogenes based on 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
- •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, and fever.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 760
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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;
研究者
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