Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Doxycycline; Azithromycin; Augmentin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.; Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Intervention MeSH terms: Azithromycin; Doxycycline; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment