Moxifloxacin for acute bacterial sinusitis
Background Information of the Condition
Acute bacterial sinusitis is a common, usually self-limited condition often associated with allergies and environmental irritants, as well as co-infection with viruses and fungi. Acute bacterial sinusitis is 200 times less common than viral rhinosinusitis. Symptoms and signs suggesting bacterial, as opposed to viral sinusitis include purulent nasal discharge in combination with facial pain and maxillary toothache, facial swelling and tenderness. Most diagnoses are based on history and physical examination as opposed to laboratory cultures and sinus xrays, which are considered unreliable.
Drug (quoted from Product Monograph)
Category: Moxifloxacin is a fluoroquinolone class, broad-spectrum antibacterial agent.
Mechanism of Action: moxifloxacin exerts its action by inhibiting the bacterial topoisomerases II (DNA gyrase) and topoisomerases IV which interferes with DNA replication, transcription, repair, and recombination.
Indications: indicated for the treatment of adults with upper and lower respiratory tract, intra-abdominal, and infections of skin/skin structure.
Dose & Duration: The recommended dose is 400mg i.v./oral once daily for 7-10 days.
Methodology of Systematic Review
In double blind randomized controlled trials (DB RCTs), does moxifloxacin provide a significant therapeutic advantage in terms of mortality or morbidity when compared to other fluoroquinolones or other classes of antibacterial agents in the treatment of adult patients ≥ 18 years of age with acute bacterial sinusitis?
Assessment principles: Double blind randomized controlled trials comparing moxifloxacin to other fluoroquinolones or other classes of antibacterial agents in adult patients with acute bacterial sinusitis will be critically appraised. Therapeutic impact will be assessed according to the following hierarchy of health outcomes – mortality; non-fatal serious adverse events; quality of life; withdrawals due to adverse events; clinical response rates (clinical resolution of signs and symptoms of infection); microbiological response rates (bacteriological eradication of causative pathogen); and other adverse events (e.g. allergic reactions).
Search strategy: Databases searched: Medline, EMBASE and Cochrane Library (from 1966 to February 2008); the manufacturer’s submission, and references of review articles. Key search words included: “moxifloxacin/fluoroquinolones,” or “Avelox,” “randomized controlled trial,” and “sinusitis.”
No DBRCT was identified comparing moxifloxacin to other fluoroquinolones. One DBRCT, Ferguson et al 2004, compared oral moxifloxacin 400mg daily for 10 days to oral telithromycin 800mg daily. Note that Health Canada has issued a warning for telithromycin (approved: May 2003; withdrawn: Sept. 2007), stating that it is no longer officially approved for acute bacterial sinusitis, therefore this trial was not considered in this review.
Because of no available DB RCT, there is insufficient evidence to conclude that moxifloxacin provides a significant therapeutic advantage compared to other fluoroquinolones or other classes of antibiotics in clinically relevant outcomes for the treatment of adult patients with acute bacterial sinusitis.
- Product Monograph: Moxifloxacin hydrochloride (Avelox®). Antibacterial Agent. Bayer Inc., Feb. 15, 2007.
- eCPS (electronic Compendium of Pharmaceuticals and Specialties), Mar. 2008
- Ferguson, B.J., Guzetta, R.V., Spector, S.L., and Hadley, J.A. Efficacy and safety of oral telithromycin once daily for 5 days versus moxifloxacin once daily for 10 days in the treatment of acute bacterial rhinosinusitis. Otolaryngology – Head and Neck Surgery, 131: 207-214, 2004.