Acute pharyngotonsillitis Acute rhinosinusitis
Conditions
Interventions
2 g dose of azithromycin SR formulation
Sponsors
Wakayama-Okayama Otolaryngology Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 16 years or older (2) Acute pharyngotonsillitis (peritonsillitis, peritonsillar abscess), or acute rhinosinusitis.(see Diagnostic criteria) (3)Diagnosed as moderate or severe in the clinical severity (4)Written informed consent of the subject or a legally authorized representative. Diagnostic criteria Acute pharyngotonsillitis (a) Sore throat and/or swallowing pain (b)Redness or swelling of pharyngeal and/or tonsillar mucosa (c) Cryptic plugs and purulent discharge on pharynx and/or tonsils Acute rhinosinusitis (a)Purulent or mucopurulent rhinorrhea or postnasal drip (b)Facial pressure or facial pain / Frontal headache
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy judged by the scoring system at Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| *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 | — |
Countries
Japan
Outcome results
None listed