Clinical trial NCT00377403
Conditions: Acute Respiratory Infections Acute Rhinosinusitis
Keywords: rhinosinusitis, sinusitis, amoxicillin
Sponsor: Washington University School of Medicine
Start date: 2006-10-01; Completion date: 2010-08-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status, symptoms, disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70 years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative instrument. Secondary outcomes include change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making.

Arms: arm 1: Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments arm 2: Placebo for 10 days in addition to symptomatic treatments
Interventions: intervention 1: Acetaminophen intervention 2: Amoxicillin intervention 3: Dextromethorphan hydrobromide with guaifenesin intervention 4: Guaifenesin intervention 5: Pseudoephedrine Sustained Action intervention 6: Saline spray (0.65%)
Intervention descriptions: intervention 1: Symptomatic treatment:

Dose: 500mg every 4 to 6 hours for pain or fever intervention 2: Intervention drug:

Dose: 500mg tid for 10 days intervention 3: Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough intervention 4: Symptomatic treatment:

Dose: 600mg every 12 hours to thin secretions intervention 5: Symptomatic treatment:

Dose: 120mg every 12 hours for nasal congestion intervention 6: Symptomatic treatment:

Dose: 2 squeezes per nostril as needed for nasal congestion

Protocol documents: