Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media

Sanofi-aventis0 个研究点目标入组 1,500 人开始时间: 2015年3月17日最近更新: 2015年3月23日

适应症

试验速览

暂无简介。

•Patients between 6 and 72 months of age with confirmed AOM and with the following inclusion criteria participated:
•Recent and rapid onset of AOM symptoms and signs
•Presence of middle ear fluid (MEF) on otoscopy
•Otalgia or ear tugging or touching
•At least 1 of the following clinical findings not specific to AOM: fever (>38°Celsius), vomiting, diarrhea, anorexia, sleep disturbance, or irritability
•Tympanometry exhibiting the following results: Type B curve or positive pressure peak curves
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1500
•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

•Uncertain diagnosis of AOM or mild to moderate symptoms and signs of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days.
•Otorrhea or tympanostomy tube present in the ear to be evaluated;
•Otitis externa;
•Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with <25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection;
•Known congenital long QT syndrome;
•Known or suspected uncorrected hypokalemia (=3 mmol/L [mEq/L]), hypomagnesemia, bradycardia (<50 bpm);
•Myasthenia gravis;
•Known impaired renal function, as shown by creatinine clearance =25 mL/min;
•History of hypersensitivity or intolerance to macrolides or azithromycin;
•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.

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