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

Sinusitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:AzithromycinSubjects 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:AugmentinIf 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

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Doxycycline, 3 weeksSubjects 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.

Doxycycline, 6 weeksSubjects 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.

Azithromycin, 3 weeksSubjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.

Azithromycin, 6 weeksSubjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.

Study Status

Completed

Start Date: February 2013

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Adam Zanation, MD

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01825408

Discuss Augmentin