A prospective, randomized, open-label, active-controlled study in adult subjects with acute bacterial sinusitis comparing the clinical efficacy of telithromycin (KETEK®) 800 mg once a day for 5 days versus amoxicillin-clavulanic acid (AUGMENTIN®) 875/125 mg twice a day for 10 days.

Aventis Intercontinental - Sanofi-aventis0 个研究点目标入组 298 人开始时间: 2004年9月16日最近更新: 2012年3月19日

适应症

试验速览

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•Clinical diagnosis of ABS (signs and symptoms lasting longer than 7 days and less than 28 days, purulent anterior or posterior nasal discharge, one additional major sign and symptom or two minor signs and symptoms.
•The major and minor signs and symptoms will be defined as the following: Major signs and symptoms: facial pain / pressure / tightness over the maxillary sinuses, nasal congestion / obstruction, change in the perception of smell (hypoanosmia / anosmia), fever (temperature > 38° C [100.4 F] (oral) / > 38.5° C [101.2 F] (tympanic) / > 39° C [102.2 F] (rectal)),
•Minor signs and symptoms: headache, halitosis, dental pain, ear pressure/fullness, cough, fatigue,and radiological confirmation of diagnosis (presence of air/fluid level,total opacification,mucosal thickening > 10 mm)
•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

•Recurrent sinusitis, sinusitis requiring other treatment than antibiotherapy, previous antibiotherapy in the last 30 days, previous corticotherapy, sinus surgery, sinus puncture / lavage in the last 7 days, known major obstructive anatomic / functional lesions in nasopharynx, symptomatic allergic sinusitis and / or rhinitis …

发起方

Aventis Intercontinental - Sanofi-aventis