Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis - Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis

Wakayama-Okayama Otolaryngology Pharma0 个研究点目标入组 300 人开始时间: 2010年12月18日最近更新: 2023年10月17日

适应症

试验速览

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•(1)Patients with known or suspected hypersensitivity or intolerance to azithromycin, or other macrolides (2)Patients who require additional systemic antibiotic therapy (3)Pregnant or lactating women (4)Patients who have a history of severe heart diseases (5)Hepatic dysfunction (AST, ALT, total bilirubin > 5 times institutional normal value) (6)Severe renal dysfunction ( serum creatinine > 2.0 mg/dL) (7)Severe underlying disease; patients in which clinical evaluation is difficult because of confounding diseases. (e.g., collagen disease, leukemia, advanced cancer etc.) (8)Patients required to have fobidden concomitant medication or treatment (9)Patients showing improvement of symptoms by the other antibiotic therapy (10) Administration of azithromycin ER 7 days before starting azithromycin SR (11) Patients with any gasrtointestinal disturbances that might affect drug absorption (12)Patients with inability or unwillingness to swallow suspension (13)For other reasons, patients determined to be inappropriate for study entry by investigator. Acute pharyngotonsillitis (14)Patients with history of rheumatic fever Acute rhinosinusitis (15) Patients who have had nasal/paranasal sinus surgeris within 3 months prior to the study (except diagnostic surgical procedures) (16)Complicated sinusitis (e.g. osteomyelitis, Pott's puffy tumor, or malignant sinus diseases) (17)Nosocomial sinusitis

发起方

Wakayama-Okayama Otolaryngology Pharma