Meta-analysis of trials evaluating parenteral antimicrobial therapy for skin and soft tissue infections.
BACKGROUND
Many trials have been carried out to determine the effectiveness of antimicrobial agents in treating skin and soft tissue infections. The results of these studies are often utilized to make determinations about the use of these antimicrobials against other types of infections. Despite the importance of these trials in determining clinical care, we hypothesized that many of these studies failed to include a variety of infections of significant enough severity to effectively draw objective conclusions about antimicrobial efficacy.


METHODS
We conducted a modified PubMed search to identify studies of antimicrobial agents in treating soft tissue infections that were published from 1998 through 2008. We then evaluated these trials for specific recommended study criteria, which were based on published US Food and Drug Administration guidelines for the conduct of trials of antimicrobials for soft tissue infection.


RESULTS
Seventeen studies were identified for inclusion in the trial. Upon review, only 30% of trials required both local and systemic signs of infection for inclusion in the trial. One trial stratified results on the basis of operative intervention, less than half reported patient comorbidities, and only 53% provided a specific definition for "cure."


CONCLUSIONS
Our meta-analysis of current trials evaluating antimicrobial therapy for skin and soft tissue infections revealed substantial shortcomings in the design of most of these trials. These data provide evidence for the importance of designing specialist panels to objectively evaluate studies and photographs of included infections to ensure that conclusions drawn from these trials concerning clinical practice are justified.
McClaine
Rebecca J
RJ
Department of Surgery, University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0558, USA.
Husted
Thomas L
TL
Hebbeler-Clark
Renee S
RS
Solomkin
Joseph S
JS
D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D016032:Randomized Controlled Trials as Topic; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D018461:Soft Tissue Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States
D000890:Anti-Infective Agents