Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis

Treatments: Drug: oral levofloxacin; Drug: nebulized levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01988779

45566

Details and patient eligibility

About

The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.

Full description

See brief summary.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults (age ≥ 18).
2. Diagnosis of CRS.
3. Worsening sinonasal symptoms.
4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
5. English speaking.
6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).
7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.

Exclusion criteria

1. Patients < 18 years of age.
2. Treatment with systemic or topical antibiotics within the last 1 month.
3. Pregnant women.
4. Non-English speaking persons.
5. Systemically ill at initial visit necessitating treatment prior to culture data.
6. Allergies to chosen susceptible antibiotics.
7. Sinonasal culture with less than 1+ growth.
8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.
9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
10. Patients with immunodeficiencies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups

oral placebo with nebulized intranasal levofloxacin

Active Comparator group

Description:

Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days

Treatment:

Drug: nebulized levofloxacin

Drug: oral levofloxacin

oral antibiotics with nebulized intranasal placebo

Active Comparator group

Description:

Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.

Treatment:

Drug: nebulized levofloxacin

Drug: oral levofloxacin