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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Adam Zanation, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01825408
First received: March 18, 2013
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Sinusitis
Drug: Doxycycline
Drug: Azithromycin
Drug: Augmentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Number of patients recommended for sinus surgery after 3 weeks of antibiotic therapy [ Time Frame: 4-5 weeks after starting antibiotics ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Quality of Life after 3 weeks of antibiotics [ Time Frame: 4-5 weeks after starting antibiotics ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Doxycycline
Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID 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
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.
Drug: Doxycycline
Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID 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
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.
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
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.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825408

Contacts
Contact: Emily Cohn, BSPH 9193570977 emily_cohn@med.unc.edu
Contact: Robert Taylor 7169035050 rjtaylor@email.unc.edu

Locations
United States, North Carolina
Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Adam Zanation, MD         
Sub-Investigator: Charles Ebert, MD, MPH         
Sub-Investigator: Brent Senior, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Adam Zanation, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Adam Zanation, MD, Assistant Professor of Otolaryngology/Head and Neck Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01825408     History of Changes
Other Study ID Numbers: 12-2377
Study First Received: March 18, 2013
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amoxicillin-Potassium Clavulanate Combination
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014