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| |  Moxifloxacin Shows Benefits for Patients With Odontogenic Inflammatory Infiltrates: Presented at ECCMID By Chris Berrie BARCELONA, Spain -- April 28, 2008 -- Moxifloxacin is significantly more effective at reducing pain than clindamycin, is well tolerated, and shows an improved clinical efficacy relative to clindamycin for treatment of odontogenic inflammatory infiltrates, according to results of a prospective, randomised, double-blind, comparative, phase 2 trial. The study was presented here at the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) by principal investigator Georg Cachovan, MD, Lecturer, Centre for Oral and Dental Medicine, Department of Restorative and Preventative Dentistry, University Medical Centre, Hamburg-Eppendorf, Germany. Odontogenic infiltrates and abscesses are mainly caused by necrotic pulp or by bacterial invasion from periodontal tissue that penetrates into the soft and bony oromaxillofacial tissues. Infiltrates are characterised by a dense consistency and have diffuse borders, while abscesses have mostly fluctuating swellings and well-defined borders, Dr. Cachovan detailed in his presentation on April 19. Dr. Cachovan and colleagues designed their study as a systematic evaluation of moxifloxacin versus clindamycin for treatment of patients aged >18 years with a diagnosis of gingival inflammatory infiltrates or odontogenic abscesses (dentoalveolar, periodontal or pericoronitis). The intention-to-treat (ITT) population consisted of 21 moxifloxacin-treated patients and 19 clindamycin-treated patients with inflammatory infiltrates, as well as 15 moxifloxacin-treated patients and 16 clindamycin-treated patients with odontogenic abscesses. Clinical assessments for the ITT population were carried out on days 2 or 3, day 5, and at the end of treatment. Follow-up was on days 6 or 7. Moxifloxacin was administered as a single dose of 400 mg, while clindamycin was administered as 4 doses of 300 mg each. The primary endpoint was mean pain reduction according to the Visual Analog Scale (VAS). The secondary endpoints included clinical efficacy, medication tolerability, and microbiological features. At the clinical assessment on day 2/3, in the infiltrate group the reductions in pain showed benefit for moxifloxacin (61.0%) over clindamycin (23.4%), with a significant difference of 37.6% (95% confidence interval [CI], 11.6%, 63.8%; P = .006). However, in the abscess group, significance was not reached for the difference between moxifloxacin (55.8%) and clindamycin (42.7%), a difference of 13.1% (95% CI, -15.5%, 41.7%; P = .358). These effects were paralleled in the day-5 analysis at the end of treatment. Clinical assessment was determined according to healing, amelioration, failure, and relapse, with different parameters considered, such as decline of inflammatory sites, decline of swelling, occurrence of pus, the need for surgical treatment for the infiltrate group, and how wide the patient could open his mouth. With no treatment failures in the infiltrate moxifloxacin group, the clinical benefits for moxifloxacin over clindamycin reached statistical significance at day 2/3 (P = .003) and day 5 (P = .001). However, again, although moxifloxacin-treated patients had fewer treatment failures and more healing, the difference in clinical benefits between moxifloxacin and clindamycin did not reach significance at day 2/3 (P = .372) or day 5 (P = .450). "We observed some moderate adverse events in all groups," added Dr. Cachovan, although there were fewer seen for infiltrate/abscess treatment with moxifloxacin (9.5%/13.3%, respectively) as compared with clindamycin (36.8%/25.0%, respectively). In the infiltrate group, these differences reached statistical significance (P = .042). The differences mainly arose from more diarrhoea and nausea seen with clindamycin. Therefore, while no significant benefits were seen between the treatment groups for patients with odontogenic abscesses, as Dr. Cachovan said, "The present results suggest that moxifloxacin is an effective and well-tolerated alternative for the treatment of odontogenic infections." Funding for this study was provided by an unrestricted grant from Bayer Vital GmbH.
[Presentation title: Efficacy and Tolerability of Moxifloxacin Versus Clindamycin in the Treatment of Odontogenic Abscesses and Inflammatory Infiltrates (Moclindamycin Study). Abstract O83]
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