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.

Conditions

• Acute Respiratory Infections
• Acute Rhinosinusitis

Interventions

DRUG

Acetaminophen

Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever

DRUG

Amoxicillin

Intervention drug: Dose: 500mg tid for 10 days

DRUG

Dextromethorphan hydrobromide with guaifenesin

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

DRUG

Guaifenesin

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

DRUG

Pseudoephedrine Sustained Action

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

DRUG

Saline spray (0.65%)

Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Jane Garbutt, MB, ChB · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2009-05-31

Completion

2010-08-31

Countries

• United States

Study Locations