Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics
 as part of maximal medical therapy for treating chronic sinusitis and thus preventing
 patients from having to have sinus surgery. The hypothesis is that in the context of maximal
 medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at
 successfully treating chronic sinusitis.
OVERVIEW This is a prospective randomized cohort study assessing duration of antibiotics (3
 vs 6 weeks) as part of maximal medical therapy for chronic rhinosinusitis. Up to 100 subjects
 will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head
 and Neck Surgery clinics at UNC Hospitals.

 INITIAL CLINIC VISIT At the time of a clinical visit, the attending otolaryngologists will
 identify their patients with chronic rhinosinusitis (CRS) who are appropriate for maximal
 medical treatment, including antibiotics. They will introduce the study to these patients and
 invite them to learn more about it.

 If the patient is interested in learning more about the study, the study coordinators will be
 contacted to provide additional information and, if the patient would like to participate in
 the study, provide informed consent.

 If the patient is a premenopausal woman, she will be asked if she is pregnant or
 breastfeeding.

 If she is either of these, she will be excluded from the study. All remaining women will
 receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be
 excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy
 test is necessary for inclusion in the study. These women will be informed that they should
 use an effective method of birth control during the study:

 -  Combined oral contraceptives

 -  Patch contraceptives

 -  Vaginal ring contraceptives

 -  Injectable contraceptives

 -  Implantable contraceptives

 -  Intrauterine devices or intrauterine systems

 -  Tubal ligation

 -  Barrier methods of contraception (male condom, female condom, cervical cap with
 spermicide, or diaphragm with spermicide)

 -  Vasectomy of your partner in a monogamous relationship

 Women enrolled in this study will be informed that if they have a failure of birth control
 method during the course of the study or become pregnant during the study, they will be
 withdrawn from the study and further treatment will be decided according to the clinical
 withdrawn from the study and further treatment will be decided according to the clinical
 expertise of the treating otolaryngologist.

 -  The study coordinators will assign the patients a unique Subject ID that will be used on
 all patient forms with the exception of the informed consent documents and HIPAA
 authorization forms.

 -  The patient will fill out a demographics and past medical history form.

 -  Using a random-number generator, the patient will be randomized to receive either 3 or 6
 weeks of antibiotics.

 -  The subject will initially be given a prescription for empiric antibiotics.The choice of
 empiric antibiotics will differ based on the patient's nasal polyposis status:

 -  If the subject has CRS with nasal polyposis (CRSwNP), s/he will be given Doxycycline
 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for either 3 or 6
 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg
 x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care
 treatment for CRSwNP.

 -  If the subject has CRS without Nasal Polyposis (CRSwNP), s/he will be given Azithromycin
 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for either 3 or 6
 weeks duration.

 -  If purulent nasal discharge is present that is appropriate for culture, the
 otolaryngologists will send this for culture and sensitivity analysis, which they would
 normally do as part of their routine clinical care. The patients will be informed that
 if their culture and sensitivity analysis indicates that they have an infection that can
 be treated with a less broad-spectrum antibiotic, then they will be prescribed
 culture-directed antibiotics. Otherwise, the patient can continue empiric antibiotics as
 previously specified.

 -  All study participants will also be prescribed standard of care intranasal steroids, and
 encouraged to perform BID saline sinus irrigation and use yogurt/over the counter
 probiotics to reduce GI side effects of antibiotics.

 4-5 WEEKS AFTER BEGINNING TREATMENT For subjects randomized to the 3 week antibiotic group,
 these subjects will been seen in clinic.

 During this visit (study visit #2), subjects will be asked about antibiotic compliance and
 side effects. Recommendation for sinus surgery will be evaluated with video-recorded nasal
 endoscopy and a sinus CT and made based on clinical judgement.

 For subjects randomized to the 6 week antibiotic group, these subjects will be contacted by
 phone by the study coordinator to assess side effects and medication compliance.

 7-8 WEEKS AFTER BEGINNING TREATMENT

 For subjects randomized to the 6 week antibiotic group, these subjects will been seen in
 clinic.

 During this visit (study visit #2), subjects will be asked about antibiotic compliance and
 side effects. Recommendation for sinus surgery will be evaluated with video-recorded nasal
 endoscopy and a sinus CT and made based on clinical judgement.
Inclusion Criteria:

 -  Diagnosis of chronic rhinosinusitis

 -  18 years of age or older

 -  English speaking

 Exclusion Criteria:

 -  Pregnant or breastfeeding women

 -  vasculitis

 -  cystic fibrosis

 -  primary ciliary dyskinesia

 -  allergic fungal sinusitis

 -  gross immunodeficiency

 -  current use of chemotherapy

 -  insulin-dependent diabetes mellitus

 -  recent trial of maximal medical therapy