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    Novel cephalosporin fights MRSA


    Washington — Promising results were seen in a phase 2 trial of the first drug in a new class of cephalosporins active against multi-drug resistant Staphlococcus aureus, according to Markus Heep, M.D., medical microbiologist and project physician at Basilea Pharmaceutica, Ltd. in Basel, Switzerland.

    Dr. Heep
    Dr. Heep presented results of a study of ceftobiprole medocaril (BAL5788) in patients with complicated skin and skin structure infections (cSSSIs) at the 44th International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held here recently.

    Novel cephalosporin Ceftobiprole medocaril is a novel cephalosporin with potent activity in vitro against both methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus MSSA).

    Forearm abscess of a 37-year-old male patient cured after intravenous treatment with ceftobiprole during the phase 2 clinical study.
    "The pharmaceutical industry has been falling behind in the struggle to develop new antibiotics that will work against the increasing number of resistant pathogens," Dr. Heep says.

    "Bacteria that cause cSSSIs,especially MRSA, have been shown to be able to counter all currentlyavailable drugs including newer arrivals like linezolid, daptomycin and tigecycline. A drug that restoresactivity of the well-established cephalosporin class would be avaluable asset in this setting. Ceftobiprole has this potential: bactericidal anti-MRSA activity combinedwith the spectrum of third or fourthgeneration cephalosporins."

    The study In a phase 2 study of ceftobiprole medocaril for the treatment of cSSSI, 40 patients hospitalized with cSSSIs were enrolled at two sites in the U.S., twosites in the Czech Republic, and one sitein Switzerland. Study participationwas open to men, surgically sterilizedpre-menopausal women, and post-menopausal women, all between the ages of 18 and 75. Patients received ceftobiprole medocaril every 12 hours at a dose of 750 mg by intravenous infusion.

    The study was designed to evaluate efficacy after treatment duration of at least seven days, with treatment prolongation as long as 21 days permitted. At seven to 10 days after the end of treatment a test of cure (ToC) evaluation was performed, with clinical evaluation and microbiological assessments. If clinically indicated, patients were evaluated again at 28 to 35 days after discontinuation of therapy, for assessment of clinical relapse, clinical worsening or need for further treatment.

    In assessing study efficacy, theinvestigators evaluated study patients in terms of clinical cure, evolution ofclinical signs and symptoms, microbiological response as determined bybacterial culture time to microbiological cure and duration of treatment and hospitalization. Possible outcomes defining microbiological responsewere: eradication, with no growth of either the original pathogen or any newpotential pathogen; presumed eradication, indicating that the lesion had healed and no culturable material was obtained at the ToC assessment; and colonization, with growth of another organism without clinical signs or symptoms of infection; microbiological failure, defined as persistence or presumed persistence of the original pathogen, reinfection by the original pathogen, or superinfection, defined as emergence of a new pathogen with worsening of clinical signs and symptoms; and non-evaluable.

    Thirty men and 10 women, with a mean age of 44.7 years (range: 18 to 82 years), were enrolled in the study. Diagnoses were abscess (26 patients), wound (nine patients),and cellulitis (five patients), with involvement of the fascial plane (16 patients), muscle (13 patients), and subcutaneous tissue (11 patients). The majority of infections were community-acquired.

    All completed All patients completed the minimal seven days of treatment and were included in the intent-to-treat (ITT) population.


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