BUCHER HC, TSCHUDI HP, PERIAT P, WELGE-LUSSEN A, SCHINDLER C; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. L-912.

University Hospital Basel, Basel, Switzerland

BACKGROUND: Acute sinusitis is one of the leading causes for the prescription of antibiotics in general practice. Evidence on the effectiveness of antibiotics for acute sinusitis is conflicting. We investigate the effectiveness of amoxicillin/clavulanate in adults with clinically diagnosed acute sinusitis in general practice. METHODS: Patients from 2 university outpatient clinics and 30 private practices presenting with headache and repetitive putrid nasal discharge for at least 2 days are eligible. We excluded patients with chronic sinusitis, any infection during the previous 4 weeks or immune suppression. Patients are randomly allocated to amoxicillin/clavulanate 1 gram bid for 6 days or placebo. All patients are clinically evaluated, by X-ray and questionnaires at days 0 and 7 and by a standardized interview at days 14 and 28. RESULTS: The trial is still blinded and 248 of 252 needed patients have been included. Follow-up is 99.6% with 2 drop-outs. The interims analysis is based on 189 patients and done after a severe complication of a patient with a brain abscess receiving placebo. Mean days of symptoms at inclusion was 4.8 days (SD 4.1). Differences in the proportion of patients with less symptoms at day 7 and 14 were found for daily restricted activity, fatigue, sleep disorders, free breathing, taste disturbance, headache and pain on bending (p<0.01 McNemar test for all items). Patients with puce during rhinoscopy had higher differences in symptom scores than those without. The final results will be presented. CONCLUSION: This RCT will provide results with high internal and external validity, since the trial mimics the diagnostic approach to patients with clinically suspected sinusitis in general practice. Patients with puce during rhinoscopy report higher symptom scores and higher reduction from symptoms.

Publication Types:

• Meeting Abstracts

Keywords:

• Acute Disease
• Adult
• Amoxicillin
• Anti-Bacterial Agents
• Blindness
• Clavulanic Acid
• Clinical Trials as Topic
• Double-Blind Method
• Family Practice
• Humans
• Placebos
• Sinusitis
• diagnosis

Other ID:

• GWAIDS0030965

UI: 102270602

From Meeting Abstracts