Treatment of Acute Sinusitis

NCT ID: NCT00377403

Last Updated: 2012-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-08-31

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.

Conditions

Acute Respiratory Infections; Acute Rhinosinusitis

Keywords

rhinosinusitis, sinusitis, amoxicillin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Arm

Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Symptomatic treatment:

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

Amoxicillin

Intervention Type: DRUG

Intervention drug:

Dose: 500mg tid for 10 days

Dextromethorphan hydrobromide with guaifenesin

Intervention Type: DRUG

Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough

Guaifenesin

Intervention Type: DRUG

Symptomatic treatment:

Dose: 600mg every 12 hours to thin secretions

Pseudoephedrine Sustained Action

Intervention Type: DRUG

Symptomatic treatment:

Dose: 120mg every 12 hours for nasal congestion

Saline spray (0.65%)

Intervention Type: DRUG

Symptomatic treatment:

Dose: 2 squeezes per nostril as needed for nasal congestion

Symptomatic treatments only

Placebo for 10 days in addition to symptomatic treatments

Group Type: PLACEBO_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Symptomatic treatment:

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

Dextromethorphan hydrobromide with guaifenesin

Intervention Type: DRUG

Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough

Guaifenesin

Intervention Type: DRUG

Symptomatic treatment:

Dose: 600mg every 12 hours to thin secretions

Pseudoephedrine Sustained Action

Intervention Type: DRUG

Symptomatic treatment:

Dose: 120mg every 12 hours for nasal congestion

Saline spray (0.65%)

Intervention Type: DRUG

Symptomatic treatment:

Dose: 2 squeezes per nostril as needed for nasal congestion

Interventions

Acetaminophen

Symptomatic treatment:

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

Intervention Type: DRUG

Amoxicillin

Intervention drug:

Dose: 500mg tid for 10 days

Intervention Type: DRUG

Dextromethorphan hydrobromide with guaifenesin

Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough

Intervention Type: DRUG

Guaifenesin

Symptomatic treatment:

Dose: 600mg every 12 hours to thin secretions

Intervention Type: DRUG

Pseudoephedrine Sustained Action

Symptomatic treatment:

Dose: 120mg every 12 hours for nasal congestion

Intervention Type: DRUG

Saline spray (0.65%)

Symptomatic treatment:

Dose: 2 squeezes per nostril as needed for nasal congestion

Intervention Type: DRUG

Other Intervention Names

Tylenol; Amoxil; Robitussin; Mucinex OTC; Sudafed; Ocean Nasal Spray

Eligibility Criteria

Inclusion Criteria

1. The subject must be male or female, and between the ages of 18 and 70 years old.

2. The subject must have symptoms of acute bacterial rhinosinusitis.

3. The subject must be attending a participating primary care practice in the community.

4. The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.

5. The subject must have access to a phone.

Exclusion Criteria

1. The subject is less than 18 years old or more than 70 years old.

2. The subject has very mild or mild symptom severity assessed by self report.

3. The subject has an allergy to penicillin or amoxicillin.

4. The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).

5. The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).

6. The subject is thought to require intravenous antibiotics or hospital admission.

7. The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).

8. The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).

9. The subject has cystic fibrosis.

10. The subject has Type I diabetes or is taking insulin to treat diabetes.

11. The subject had prior sinus surgery.

12. The subject requires an antibiotic for a concurrent condition such as an ear infection.

13. The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.

14. Any other condition that the provider feels may interfere with the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jane Garbutt, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane Garbutt, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22337680 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21844413 (View on PubMed)

Other Identifiers

U01AI064655-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-0140

Identifier Type: -

Identifier Source: org_study_id