my personal edition > bacterial infections > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Garenoxacin Eradicates Pathogens in Complicated Skin Infections: Presented at ECCMID

By Chris Berrie

NICE, FRANCE -- April 7, 2006 -- Once-daily administration of the des-F(6)-quinolone garenoxacin is highly effective in eradicating most pathogens commonly associated with complicated skin and skin structure infections (cSSSIs), with bacteriologic eradication rates similar to those of a range of its comparators, according to research presented here at the 16^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

The more common cSSSIs include infected diabetic-foot ulcers, pressure sores, major abscesses, and post-surgical wound infections. These infections can begin by involving the skin and adjacent soft tissues, and can progress to penetrate deeper tissues, requiring aggressive surgical debridement in addition to antibiotic therapy.

"Complicated skin and skin-structure infections are a huge problem all over the world," said Dainis Krievins, MD, PhD, principal investigator and professor of surgery, department of vascular surgery, P. Stradins Clinical University Hospital, Riga, Latvia. "Even if there are quite a lot of antibiotics available, with the present problems over microbe strains becoming resistant, new antibiotics against common pathogens of cSSSIs are always very welcome."

Garenoxacin is a novel agent with a broad spectrum of activity against clinically important pathogens involved in cSSSI, including Gram-positive and Gram-negative aerobes and anaerobes, and Gram-positive cocci that are resistant to multiple drugs. The purpose of this analysis was to evaluate the microbiological efficacy of garenoxacin in the eradication of common pathogens involved in cSSSIs, and to compare this efficacy with that of other antibiotic regimens.

This analysis covered 2 phase-3 trials of garenoxacin. The first trial compared garenoxacin 600 mg intravenously (IV) without or with transition to garenoxacin 600 mg orally once daily or piperacillin/tazobactam 3.375 g IV every 6 hours, with transition to amoxicillin/clavulanate 500/125 mg orally every 8 hours for 7 to 14 days.

The second trial tested garenoxacin 600 mg orally once daily or ciprofloxacin 500 mg orally every 12 hours plus metronidazole 500 mg orally every 8 hours for 7 to 14 days.

The inclusion criteria in the first trial were for newly hospitalised subjects who were 18 years or older; the second trial required non-hospitalised subjects who were 18 years or older. In both trials, subjects had to demonstrate clinical evidence of at least 1 of the following: infected pressure sore, infected diabetic-foot ulcer, major abscess, and/or post-surgical wound infection with purulent drainage.

A total of 855 subjects were treated between the 2 trials, with 422 in the garenoxacin group and 433 in the comparator group. The overall median age was 54 years, with the majority being male (60%) and white (68%). Across these 2 treatment groups, the disease diagnoses at baseline were similar in both trials, with the most common being major abscess (total, 66.6%) and infected diabetic-foot ulcer (total, 18.5%).

Overall eradication rates for the bacterial skin pathogens obtained were 86% for the garenoxacin group and 82% for the comparators. The main pathogens considered gave the following eradication rates, respectively: all Staphylococcus aureus (SA), 88% versus 74%; methicillin-resistant SA, 72% versus 57%; quinolone-resistant SA, 73% versus 57%; all Gram-negative aerobes, 88% versus 76%; all anaerobes, 86% versus 90%.

Dr. Krievins noted that while garenoxacin was generally at least equipotent across all pathogens tested, it did show slightly higher efficacies than the comparators against some of the more resistant strains, such as the methicillin-resistant and quinolone-resistant strains.

Dr. Krievins also stressed two further aspects of garenoxacin use: "One, it is a once-daily injection, and two, you can switch to oral medication as well."

Financial support for this study was provided by Schering-Plough.


[Presentation title: Microbiological Efficacy of Garenoxacin vs Comparators in Complicated Skin and Skin Structure Infections. Abstract P1575]

E-Mail this DGDispatch to a colleague

To print, use this version