Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00377403
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00377403
Study Brief:
Protocol Section:
NCT00377403