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

This study has been completed.
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: February 16, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    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.


Enrollment: 40
Actual Study Start Date: February 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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 to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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
Results First Received: February 16, 2017
Last Updated: February 16, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Doxycycline
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017