EUCTR2014-004631-39-Outside-EU/EEA进行中（未招募）不适用
Multinational, randomized, double blind, comparative study to evaluate the efficacy and safety of telithromycin, 800 mg once daily for 5 days, versus penicillin V, 500 mg three times daily for 10 days, in adolescent and adult subjects equal to or over 13 years of age 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 equal to or over 13 years of age with the following inclusion criteria participated:
- •Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on positive result from a rapid detection test for group A streptococcal antigen
- •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: 608
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
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;
- •Known congenital prolonged QT syndrome;
- •Known or suspected uncorrected hypokalemia (=3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm);
- •Known impaired renal function, as shown by creatinine clearance =25 mL/min
- •Myasthenia gravis;
- •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.
- •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.
研究者
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