Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01825408
Recruitment Status : Completed
First Posted : April 5, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Adam Zanation, MD, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE March 18, 2013
First Posted Date  ICMJE April 5, 2013
Results First Submitted Date  ICMJE February 16, 2017
Results First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 4, 2017
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
  • Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy [ Time Frame: 4-5 weeks after starting antibiotics ]
    Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
  • Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy [ Time Frame: 7-8 weeks after initiating antibiotics ]
    Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01825408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
  • Change in Quality of Life after 3 weeks of antibiotics [ Time Frame: 4-5 weeks after starting antibiotics ]
    Quality of life will be measured at the initial clinic visit and again 4-5 weeks after starting antibiotics. The quality of life assessments used in this study are the Chronic Sinusitis Survey and the RhinoSinusitis Disability Index.
  • Change in Quality of Life after 6 weeks of antibiotics [ Time Frame: 7-8 weeks after starting antibiotics ]
    Quality of life will be measured at the initial clinic visit and again 7-8 weeks after starting antibiotics. The quality of life assessments used in this study are the Chronic Sinusitis Survey and the RhinoSinusitis Disability Index.
  • Change in Nasal endoscopy scores after 3 weeks of antibiotics [ Time Frame: 4-5 weeks after starting antibiotics ]
    Nasal endoscopy is a routine standard of care procedure to assess the sinuses. It will be performed at the initial clinic visit and again at the follow up visit. Nasal endoscopies will be scored with the Lund-Kennedy scoring system.
  • Change in Nasal Endoscopy Score following 6 weeks of antibiotics [ Time Frame: 7-8 weeks after starting antibiotics ]
    Nasal endoscopy is a routine standard of care procedure to assess the sinuses. It will be performed at the initial clinic visit and again at the follow up visit. Nasal endoscopies will be scored with the Lund-Kennedy scoring system.
  • Change in CT Score after 3 weeks of antibiotics [ Time Frame: 4-5 weeks after starting antibiotics ]
    A sinus CT within 3 months of study initiation will be graded and compared with a standard of care post-treatment CT scan using the Lund-Mackay CT scoring system.
  • Change in CT Score after 6 weeks of antibiotics [ Time Frame: 7-8 weeks after starting antibiotics ]
    A sinus CT within 3 months of study initiation will be graded and compared with a standard of care post-treatment CT scan using the Lund-Mackay CT scoring system.
  • Number of patients with antibiotic side effects after a 3 week course of antibiotics [ Time Frame: 4-5 weeks after starting antibiotics ]
    The most frequent side effect of antibiotics is GI upset. At the follow up visit, subjects will be asked about their medication compliance and what, if any, side effects they experienced.
  • Number of subjects with antibiotic side effects after a 6 week course of antibiotics [ Time Frame: 4-5 weeks and 7-8 weeks after initiating antibiotics ]
    The most frequent side effect of antibiotics is GI upset. 4-5 weeks after starting antibiotics, subjects in the 6-week of antibiotic group will be contacted by the study coordinators and medication compliance and side effects will be assessed. Any adverse outcomes will be reported to the primary investigator. At the follow up visit, subjects will be asked about their medication compliance and what, if any, side effects they experienced.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Official Title  ICMJE A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • Drug: Doxycycline
    Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
  • Drug: Azithromycin
    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.
  • Drug: Augmentin
    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
Study Arms  ICMJE
  • Active Comparator: Doxycycline, 3 weeks
    Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 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 patients with chronic sinusitis with nasal polyps.
    Interventions:
    • Drug: Doxycycline
    • Drug: Augmentin
  • Active Comparator: Doxycycline, 6 weeks
    Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 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 patients with chronic sinusitis with nasal polyps.
    Interventions:
    • Drug: Doxycycline
    • Drug: Augmentin
  • Active Comparator: Azithromycin, 3 weeks
    Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
    Interventions:
    • Drug: Azithromycin
    • Drug: Augmentin
  • Active Comparator: Azithromycin, 6 weeks
    Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
    Interventions:
    • Drug: Azithromycin
    • Drug: Augmentin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2013)
100
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01825408
Other Study ID Numbers  ICMJE 12-2377
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Zanation, MD, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Zanation, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP