Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
- Conditions
- Acute pharyngotonsillitis Acute rhinosinusitis
- Registration Number
- JPRN-UMIN000004743
- Lead Sponsor
- Wakayama-Okayama Otolaryngology Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy judged by the scoring system at Day 4
- Secondary Outcome Measures
Name Time Method *Clinical efficacy judged by the scoring system at Day 8 *Bacteriological efficacy *Change of clinical symptoms on the patients' diary *Antipyretic rate(<37.0) at day4 and day8 *Improvement rate of each symptom at day4 and day8 *Clinical efficacy judged by investigators *Recurrence rate at day15