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The development of a staphylococcus aureus four antigen vaccine for use prior to elective orthopedic surgery.

ABSTRACT: Staphylococcus aureus (S. aureus) is a challenging bacterial pathogen which can cause a range of diseases, from mild skin infections, to more serious and invasive disease including deep or organ space surgical site infections, life-threatening bacteremia, and sepsis. S. aureus rapidly develops resistance to antibiotic treatments. Despite current infection control measures, the burden of disease remains high. The most advanced vaccine in clinical development is a 4 antigen S. aureus vaccine (SA4Ag) candidate that is being evaluated in a phase 2b/3 efficacy study in patients undergoing elective spinal fusion surgery (STaphylococcus aureus suRgical Inpatient Vaccine Efficacy [STRIVE]). SA4Ag has been shown in early phase clinical trials to be generally safe and well tolerated, and to induce high levels of bactericidal antibodies in healthy adults. In this review we discuss the design of SA4Ag, as well as the proposed clinical development plan supporting licensure of SA4Ag for the prevention of invasive disease caused by S. aureus in elective orthopedic surgical populations. We also explore the rationale for the generalizability of the results of the STRIVE efficacy study (patients undergoing elective open posterior multilevel instrumented spinal fusion surgery) to a broad elective orthopedic surgery population due to the common pathophysiology of invasive S. aureus disease and commonalties of patient and procedural risk factors for developing postoperative S. aureus surgical site infections.

SUBMITTER: Gurtman A

PROVIDER: S-EPMC6422482 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The development of a staphylococcus aureus four antigen vaccine for use prior to elective orthopedic surgery.

Gurtman A A Begier E E Mohamed N N Baber J J Sabharwal C C Haupt R M RM Edwards H H Cooper D D Jansen K U KU Anderson A S AS

Human vaccines & immunotherapeutics 20180927 2

Staphylococcus aureus (S. aureus) is a challenging bacterial pathogen which can cause a range of diseases, from mild skin infections, to more serious and invasive disease including deep or organ space surgical site infections, life-threatening bacteremia, and sepsis. S. aureus rapidly develops resistance to antibiotic treatments. Despite current infection control measures, the burden of disease remains high. The most advanced vaccine in clinical development is a 4 antigen S. aureus vaccine (SA4A ...[more]

PMID: 30215582

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Project description:BACKGROUND:This study assessed incidence, risk factors, and outcomes of Staphylococcus aureus infections (SAI) following endoprosthetic hip or knee, or spine surgeries. METHODS:Adult patients with at least one of the selected surgeries from 2012 to 2015 captured in a German sickness fund database were included. SAI were identified using S. aureus-specific ICD-10 codes. Patients with certain prior surgeries and infections were excluded. Cumulative incidence and incidence density of post-surgical SAI were assessed. Risk factors, mortality, healthcare resource utilization and direct costs were compared between SAI and non-SAI groups using multivariable analyses over the 1 year follow-up. RESULTS:Overall, 74,327 patients who underwent a knee (28.6%), hip (39.6%), or spine surgery (31.8%) were included. The majority were female (61.58%), with a mean age of 69.59 years and a mean Charlson Comorbidity Index (CCI) of 2.3. Overall, 1.92% of observed patients (20.20 SAI per 1000 person-years (PY)) experienced a SAI within 1 year of index hospitalization. Knee surgeries were associated with lower SAI risk compared with hip surgeries (Hazard Ratio (HR) = 0.8; p = 0.024), whereas spine surgeries did not differ significantly from hip surgeries. Compared with non-SAI group, the SAI group had on average 4.4 times the number of hospitalizations (3.1 vs. 0.7) and 7.7 times the number of hospital days (53.5 vs. 6.9) excluding the index hospitalization (p < 0.001). One year post-orthopedic mortality was 22.38% in the SAI and 5.31% in the non-SAI group (p < 0.001). The total medical costs were significantly higher in the SAI group compared to non-SAI group (42,834€ vs. 13,781€; p < 0.001). Adjusting for confounders, the SAI group had nearly 2 times the all-cause direct healthcare costs (exp(b) = 1.9; p < 0.001); and 1.72 times higher risk of death (HR = 1.72; p < 0.001). CONCLUSIONS:SAI risk after orthopedic surgeries persists and is associated with significant economic burden and risk of mortality. Hence, risk reduction and prevention methods are of utmost importance.

Project description:BackgroundAn unmet need to prevent Staphylococcus aureus (SA) infections after cardiothoracic surgery persists despite current practices. Cost-effective implementation of preventive strategies requires contemporary knowledge about modifiable risk factors.MethodsFrom 2007 to 2011, an international, double-blind, randomized placebo-controlled trial of a novel SA vaccine (V710) was conducted in 7664 adults scheduled for median sternotomy at 164 sites. We analyzed SA infections developing up to 360 days postoperatively in 3832 placebo recipients.ResultsCoronary artery bypass grafting was performed in 80.8% (3096 of 3832) of placebo recipients. The overall incidence of any postoperative SA infection was 3.1% (120 of 3832). Invasive SA infections (including bacteremia and deep sternal-wound infections) developed in 1.0%. Methicillin-resistant SA (MRSA) accounted for 19% (23 of 120) of SA infections, with 57% (13 of 23) of the MRSA infections occurring in diabetic patients. All-cause mortality was 4.1% (153 of 3712) in patients without SA infection, 7.2% (7 of 97) in methicillin-susceptible SA (MSSA) infections, and 17.3% (4 of 23) in MRSA infections (P < .01). Staphylococcus aureus nasal carriage was detected preoperatively in 18.3% (701 of 3096) patients, including 1.6% colonized with MRSA. Postoperative SA infections occurred in 7.0% (49 of 701) of colonized patients versus 2.3% (71 of 3131) of patients without colonization (relative risk = 3.1 [95% confidence interval, 2.2-4.4]).ConclusionsIn this large international cohort of patients undergoing cardiac surgery and observed prospectively, invasive postoperative SA infections occurred in 1% of adult patients despite modern perioperative management. The attributable mortality rates were 3% for MSSA and 13% for MRSA infections. Preoperative nasal colonization with SA increased the risk of postoperative infection threefold. The utility of strategies to reduce this incidence warrants continued investigation.

Project description:BackgroundHealth behavior changes made by patients during the perioperative period can impact the outcomes and success of elective surgeries. However, there remains a limited understanding of how best to support patients during this time, particularly through the use of digital health interventions. Recognizing and understanding the potential unmet needs of elective orthopedic surgery patients is central to motivating healthier behavior change, improving recovery, and optimizing overall surgical success in the short and long term.ObjectiveThe aim of this study is to explore patient perspectives on technology features that would help support them to change their lifestyle behaviors during the pre- and postoperative periods, and that could potentially maintain long-term healthy lifestyles following recovery.MethodsSemistructured interviews with pre- and postoperative elective orthopedic patients were conducted between May and June 2020 using telephone and video call-based software. Patient perspectives on the use of digital technologies to complement current surgical care and support with lifestyle behavior changes were discussed. Interviews were audio recorded and transcribed verbatim. Reflexive thematic analysis enabled the development of themes from the data, with QSR NVivo software (version 12) facilitating data management. Ethical approval was obtained from the National Health Service Health Research Authority.ResultsA total of 18 participants were interviewed. Four themes were developed from the data regarding the design and functionality of digital technologies to best support the perioperative journey. These center around an intervention's ability to incorporate interactive, user-centered features; direct a descriptive and structured recovery; enable customizable, patient-controlled settings; and deliver both general and specific surgical advice in a timely manner. Interventions that are initiated preoperatively and continued postoperatively were perceived as beneficial. Interventions designed with personalized milestones were found to better guide patients through a structured recovery. Individualized tailoring of preparatory and recovery information was desired by patients with previously high levels of physical activity before surgery. The use of personalized progression-based exercises further encouraged physical recovery; game-like rewards and incentives were regarded as motivational for making and sustaining health behavior change. In-built video calling and messaging features offered connectivity with peers and clinicians for supported care delivery.ConclusionsSpecific intervention design and functionality features can provide better, structured support for elective orthopedic patients across the entire surgical journey and beyond. This study provides much-needed evidence relating to the optimal design and timing of digital interventions for elective orthopedic surgical patients. Findings from this study suggest a desire for personalized perioperative care, in turn, supporting patients to make health behavior changes to optimize surgical success. These findings should be used to influence future co-design projects to enable the design and implementation of patient-focused, tailored, and targeted digital health technologies within modern health care settings.

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The development of a staphylococcus aureus four antigen vaccine for use prior to elective orthopedic surgery.

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The development of a staphylococcus aureus four antigen vaccine for use prior to elective orthopedic surgery.

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