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

NCT01825408 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 12-2377
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (2)

• Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy

  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.

  4-5 weeks after starting antibiotics

• Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy

  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.

  7-8 weeks after initiating antibiotics

Study Arms (4)

Doxycycline, 3 weeks

ACTIVE COMPARATOR

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; Drug: Augmentin

Doxycycline, 6 weeks

ACTIVE COMPARATOR

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; Drug: Augmentin

Azithromycin, 3 weeks

ACTIVE COMPARATOR

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; Drug: Augmentin

Azithromycin, 6 weeks

ACTIVE COMPARATOR

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; Drug: Augmentin

Interventions

Doxycycline DRUG

Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Doxycycline, 3 weeks; Doxycycline, 6 weeks

Azithromycin DRUG

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.

Azithromycin, 3 weeks; Azithromycin, 6 weeks

Augmentin DRUG

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

Azithromycin, 3 weeks; Azithromycin, 6 weeks; Doxycycline, 3 weeks; Doxycycline, 6 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic rhinosinusitis
• years of age or older
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Doxycycline; Azithromycin; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Adam Zanation
• Organization: UNC Department of Otolaryngology

adam_zanation@med.unc.edu

Study Officials

• Adam Zanation, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology/Head and Neck Surgery

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: April 5, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)