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.
"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 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.
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