Iclaprim Eradicates Complicated Skin and Skin Structure Infections: Presented at ECCMID

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Title: Iclaprim Eradicates Complicated Skin and Skin Structure Infections: Presented at ECCMID
URL: http://www.pslgroup.com/dg/21FF02.htm
Doctor's Guide
April 22, 2008

By Chris Berrie

BARCELONA, Spain -- April 22, 2008 -- The bacteriocidal antibiotic iclaprim has a good safety profile, is well tolerated, and is statistically noninferior to linezolid for clinical cure and microbiological eradication in patients with complicated skin and skin structure infection (cSSSI), according to results of a multicentre, randomised, double-blind, phase 3 trial.

Coinvestigator Paul Hadváry, PhD, Head of Development, Arpida AG, Reinach, Switzerland, presented the findings here on April 19 at the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

Bacterial infections of the skin and underlying soft tissue commonly require antibiotic treatment during short-term and long-term hospitalisation, with some 10% of cases involving cSSSIs.

Iclaprim has an extended spectrum of activity and potent bacteriocidal activity against several important antibiotic-resistant strains. Dr. Hadváry and colleagues therefore conducted the Study of Intravenous (IV) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2) study to compare the safety and efficacy of iclaprim for treatment of patients with cSSSIs against linezolid, a well-established therapy for serious Gram-positive cSSSIs.

Patients were hospitalised with established cSSSIs that were suspected or proven to be caused by Gram-positive pathogens. Exclusion was based on body mass index >40 kg/m², uncomplicated skin and skin structure infection or self-limiting infections, recent administration of antimicrobial therapy, severe renal or hepatic impairment, and infected diabetic foot ulcers or decubitus ulcers.

Clinical cure was defined as resolution of baseline cSSSI signs and symptoms, with the by-pathogen assessment according to eradication of the baseline causative organisms.

The researchers randomised 251 patients to receive iclaprim (mean age, 47.1 years; male, 63.3%) and 243 to receive linezolid (mean age, 46.8 years; male, 63.4%). Iclaprim was dosed at 0.8 mg/kg and linezolid at 600 mg. Treatments were carried out as 30-minute IV infusions every 12 hours for 10 to 14 days.

The frequencies of the most prevalent types of infection at baseline were similar in the 2 treatment groups, and included wound infections (45%), major abscesses (30%), deep or extensive cellulitis (28%), infected ulcers (8%), and infected burns (7%).

For the intention-to-treat patient population at the test-of-cure analysis (7-14 days posttreatment), the overall clinical cure rates achieved were 81.3% for iclaprim and 81.9% for linezolid, with a consequent, nonsignificant difference (iclaprim-linezolid) of -0.6% (95% confidence interval, -8.83%, 4.95%).

Staphylococcus aureus was the most common pathogen at baseline (76.6%); 50% of these cases were methicillin-resistant S aureus.

The overall and by-pathogen bacteriological responses were similar in the 2 treatment arms.

Safety profiles in the iclaprim and linezolid treatment groups were, respectively: 25.6% and 30.3% of patients had at least 1 possible drug-related adverse event. Those reported by more than 4% of patients were laboratory investigations (12.4% vs 11.1%), gastrointestinal disorders (9.6% vs 15.6%), nervous system disorders (6.4% vs 10.2%), skin and subcutaneous tissue disorders (5.2% vs 4.9%), and general disorders and administration site conditions (4.8% vs 4.1%).

The researchers concluded that iclaprim compared favourably with linezolid, with similar clinical cure and microbiological eradication rates. Iclaprim represents an effective alternative treatment for patients with cSSSIs, they noted.

Funding for the ASSIST-2 trial was provided by Arpida AG.

[Presentation titles: Clinical Efficacy of Iclaprim in Complicated Skin and Skin Structure Infection (cSSSI): Preliminary Results From the ASSIST-2 Clinical Trial. Abstract P545. Assessment of Safety and Tolerability Profiles After Claprim Administration in Complicated Skin and Skin Structure Infection (cSSSI) From the ASSIST-2 Clinical Trial (Arpida's Skin and Skin Structure Infection Study-2). Abstract P547]

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