ABSTRACT
Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 microg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab.
Subject(s)
Antibodies, Monoclonal/pharmacokinetics , Bacteremia/drug therapy , Staphylococcal Infections/therapy , Staphylococcus aureus/drug effects , Adult , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/therapeutic use , Area Under Curve , Double-Blind Method , Female , Humans , Male , Middle AgedABSTRACT
In an attempt to reduce sternal infections caused by Staphylococcus aureus, a protocol was introduced that included the administration of intranasal mupirocin calcium 2% before surgery to patients undergoing cardiothoracic surgery. Surveillance data indicated a 55% reduction in the rate of deep sternal wound infections caused by S aureus and superficial sternal wound infections have declined from 25 to 6 since the adoption of the protocol. At the study institution, this protocol is now an ongoing process to reduce the incidence of sternal infections caused by S aureus among cardiothoracic patients.
Subject(s)
Coronary Artery Bypass/adverse effects , Infection Control/methods , Quality Assurance, Health Care , Surgical Wound Infection/prevention & control , Administration, Intranasal , Clinical Protocols/standards , Humans , Incidence , Infection Control/economics , Mupirocin/administration & dosage , Mupirocin/therapeutic use , Quality Assurance, Health Care/economics , Staphylococcal Infections/diagnosis , Staphylococcal Infections/drug therapy , Staphylococcal Infections/microbiology , Staphylococcal Infections/prevention & control , Staphylococcus aureus , Surgical Wound Infection/drug therapy , Surgical Wound Infection/economics , Surgical Wound Infection/microbiologyABSTRACT
Nasal carriage of Staphylococcus aureus is a major risk factor for the development of S. aureus infection, including skin and soft tissue infections and foreign body infections, such as catheter-associated bacteremia and peritonitis. In this article, we review the recent literature on S. aureus nasal carriage, including the emergence of methicillin- resistant S. aureus in the community, the pathophysiology of nasal carriage, and the epidemiology and prevention of S. aureus infections associated with nasal carriage.
