Phase 4
N=40
Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01825408 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy — 7; 8; 0; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Doxycycline (Drug); Azithromycin (Drug); Augmentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy |
7; 8; 0; 6 | — |
| PRIMARY Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy |
5; 8; 2; 4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01825408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.