Moxifloxacin More Effective Than Clindamycin in Treating Inflammatory Infiltrates

Chris Berrie, MA, MPhil, PhD

April 23, 2008

April 23, 2008 (Barcelona) — Moxifloxacin (MXF) is well tolerated, is significantly more effective at reducing pain, and shows significantly improved clinical efficacy over clindamycin (CLI) in the treatment of patients with inflammatory infiltrates, according to the findings of a prospective, randomized, double-blind, comparative phase 2 clinical trial.

This study was presented here on behalf of the Moxifloxacin Clindamycin (MOCLI) Study investigators by Georg Cachovan, MD, from the Centre for Oral and Dental Medicine, and a lecturer in the Department of Restorative and Preventative Dentistry at the University Medical Centre in Hamburg-Eppendorf, Germany, during the 18th European Congress of Clinical Microbiology and Infectious Diseases.

As Dr. Cachovan indicated in his presentation, "Odontogenic infections are mainly caused by necrotic pulp or by bacterial invasion from periodontal tissue." These are usually mixed bacterial infections, and they penetrate mostly into the soft and bony oromaxillofacial tissues to produce submucosal infiltrates and abscesses.

These infiltrates are characterized by a dense consistency and diffuse borders, whereas abscesses have swellings that are mostly fluctuating, have well-defined borders, and can contain pus.

The aim of the study was to systematically evaluate MXF for the treatment of these odontogenic infections in a comparison with the active control of CLI, with the primary endpoint of pain reduction according to the visual analog scale (VAS). The secondary endpoints were for clinical efficacy, medication tolerability, and microbiological features.

The main inclusion criteria were for adult patients (>18 years old) with a diagnosis of odontogenic abscesses (dentoalveolar, periodontal, or pericoronitis) or gingival inflammatory infiltrates. The main exclusions included MXF/quinolone and CLI/lincosamide allergies, pregnancy, cardiac arrhythmia, diabetes mellitus, HIV infection, electrolyte disturbance, and renal or hepatic dysfunction. Importantly, patients with a need for parenteral antibiotics were excluded.

The trial protocol included the initial separate randomization of the infiltrate/abscess patient groups to receive either MXF (n = 21/15; mean ages, 43.6/45.0 years; men, 57%/60%, respectively) or CLI (n = 19/16; mean ages, 45.4/38.4 years; men, 68%/69%, respectively). Clinical assessments were according to the intention-to-treat population (n = 71) and were carried out on days 2 or 3 and at end of treatment (EOT) on day 5. Follow-up took place on days 6 and 7.

Patient medication consisted of 5 tablets taken daily for 5 days. Patients in the MXF group took 1 × MXF 400 mg plus 4 × CLI dummy; patients in the CLI group took 4 × CLI 300 mg plus 1 × MXF dummy.

The primary endpoint for the clinical assessment on day 2/3 was expressed as mean percentage reduction in pain according to the VAS. For the infiltrate group, MXF treatment (61.0%) showed benefit over CLI treatment (23.4%), with a significant difference of 37.6% (95% confidence interval [CI], 11.6% – 63.8%; P = .006). Although the patients with abscesses saw good levels of pain reduction in both treatment groups, significance was not reached for the difference between MXF (55.8%) and CLI (42.7%) treatment, with a difference of 13.1% (95% CI, −15.5% – 41.7%; P = .358). These effects were maintained in the 5-day EOT analysis.

Clinical assessment was determined according to healing, amelioration, failure, and relapse. As Dr. Cachovan said, "We used different parameters, 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."

Here the infiltrate MXF group showed no treatment failures, with benefits for MXF over CLI treatment reaching statistical significance for both the day 2/3 (P = .003) and day 5 (P = .001) assessments. However, again, although there were fewer failures and more healing with MXF over CLI, they did not reach significance for either the day 2/3 (P = .372) or day 5 (P = .450) clinical assessments.

The assessment of treatment tolerability saw fewer patients with moderate adverse events for infiltrate/abscess treatment with MXF (9.5%/13.3%, respectively) compared with CLI (36.8%/25.0%, respectively), with these differences in the infiltrate group reaching statistical significance (P = .042). The differences mainly arose from the adverse events of diarrhea (4.8%/6.7% vs 31.6%/12.5%, respectively) and nausea (0.0%/0.0% vs 10.5%/6.3%, respectively).

Therefore, Dr. Cachovan said that in patients with odontogenic inflammatory infiltrates, MXF was indeed significantly more effective at reducing pain, while also showing significantly better clinical efficacy than CLI. However, no significant differences were found between the treatment groups for patients with odontogenic abscesses.

As cochairman of this session Ben E. de Pauw, MD, professor of medicine in the departments of Blood Transfusion and Haematology at the University Medical Centre St. Radboud, Nijmegen, the Netherlands, told Medscape Infectious Diseases, "this study was rather limited because the data that were presented did not include microbiological data and adjuvant interventions, like surgery, which is important." His need to see the microbiology data related to the possibility of there being a lot of gram-negative pathogens too, which would prompt further questioning, although he added, "But as such, the results don't surprise me: Moxifloxacin is a better drug than clindamycin, and this proves its value under these circumstances."

This study was supported by an unrestricted grant from Bayer Vital GmbH. Dr. de Pauw and Dr. Cachovan have disclosed no relevant financial relationships.

18th European Congress of Clinical Microbiology and Infectious Diseases: Abstract O83. Presented April 18, 2008.

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