Treatment of Acute Sinusitis
Summary
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
Timeline
- Start
- 2006-10
- Primary completion
- 2009-05
- Completion
- 2010-08
Publications
- Garbutt JM, Banister C, Spitznagel E, Piccirillo JF. Amoxicillin for acute rhinosinusitis: a randomized controlled trial. JAMA. 2012 Feb 15;307(7):685-92. doi: 10.1001/jama.2012.138.
- Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2011 Aug;137(8):792-7. doi: 10.1001/archoto.2011.120.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 500 mg | — |
| Background | Acetaminophen | Small molecule | 500 mg | — |
| Background | Dextromethorphan | Unknown | — | — |
| Background | Guaifenesin | Small molecule | 600 mg | — |
| Background | Pseudoephedrine | Small molecule | 120 mg | Oral |
| Background | sodium chloride | Unknown | 0.65 % | Intranasal |