Trial Assesses Shorter Moxifloxacin Therapy

by Sue Pondrom •

What is the efficacy and safety of a five-day moxifloxacin regimen in the treatment of acute bacterial rhinosinusitis (ABRS)?

Background: There is a lack of clarity regarding the role of antimicrobials in ABRS treatment. Although current guidelines encourage the use of antimicrobials, it is difficult to identify appropriate patients. Additionally, there would be benefits to reducing treatment duration, including lower drug exposure, greater compliance and minimized potential for resistance.

Study Design: A prospective, randomized, multicenter, 2:1 double-blind, phase IIIb clinical trial

Setting: Thirty-seven centers (ear, nose and throat practices; family practitioners; and general medical clinics) in the U.S.

Synopsis: Microbiologic assessment was provided at enrollment for 374 patients with ABRS who were given 400 mg of oral moxifloxacin or a matching placebo daily for five days. The primary end point was clinical response with secondary efficacy variables, including patient-reported symptom improvement. Although moxifloxacin did not show clinical superiority to placebo in the modified intent-to-treat (mITT) population, it did reduce the rate of clinical failure by 42.3 percent compared with placebo, and symptom duration was shorter in moxifloxacin-treated patients, who experienced greater and faster improvements overall. However, the authors said the study may have been affected by confounding factors. For example, the study was not sufficiently powered to detect a difference from placebo with a greater than estimated success rate, patients with nonbacterial sinusitis may have been included, the high use of concomitant medications in the placebo arm may have masked continuing sinusitis symptoms, the use of a sinus tap may have had an adjunctive effect on bacterial clearance and, because an arbitrary point for analysis is problematic, the test-of-cure visit may have been too early.

Bottom Line: Although five-day moxifloxacin did not show clinical superiority to placebo, researchers noted positive trends favoring moxifloxacin when assessing secondary efficacy variables, such as symptom relief. Patients on moxifloxacin also used fewer concomitant medicines.

Citation: Hadley JA, Mösges R, Desrosiers M, et al. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010;120(5):1057-1062.

—Reviewed by Sue Pondrom