PubMed Health⌕ Search

Biomedical subjects

Benjamin A Lipsky

Publications and source records attributed to Benjamin A Lipsky.

At least 19 recordsLinked to original sources
PubMed2005

Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial.

BACKGROUND: Diabetic foot infections are a common and serious problem, yet few randomised trials of adequate quality have compared the efficacy of the various antibiotic regimens available for their treatment. Our aim was to assess the efficacy and safety of ertapenem versus piperacillin/tazobactam for foot infections. METHODS: We did a randomised, double-blinded, multicentre trial in adults (n=586) with diabetes and a foot infection classified as moderate-to-severe and requiring intravenous antibiotics. We assigned patients intravenous ertapenem (1 g daily; n=295) or piperacillin/tazobactam (3.375 g every 6 h; n=291) given for a minimum of 5 days, after which oral amoxicillin/clavulanic acid (875/125 mg every 12 h) could be given for up to 23 days. Investigators retained the option to administer vancomycin to patients in either group to ensure adequate coverage for potentially antibiotic resistant Enterococcus spp and meticillin-resistant Staphylococcus aureus (MRSA). Our primary outcome was the proportion of patients with a favourable clinical response (cure or improvement) on the day that intravenous antibiotic was discontinued. Analyses were by an evaluable-patient only approach. This study is registered with , number NCT00229112. FINDINGS: Of the 576 patients treated, 445 were available for assessment at the end of intravenous therapy. Both baseline characteristics and favourable clinical response rates were similar for the 226 who received ertapenem and the 219 who received piperacillin/tazobactam (94%vs 92%, respectively; between treatment difference 1.9%, 95% CI -2.9 to 6.9). Rates of favourable microbiological responses (eradication rates and clinical outcomes, by pathogen) and adverse events did not differ between groups. INTERPRETATION: Clinical and microbiological outcomes for patients treated with ertapenem were equivalent to those for patients treated with piperacillin/tazobactam, suggesting that this once-daily antibiotic should be considered for parenteral therapy of diabetic foot infections, when deemed appropriate.

Adult↗
PubMed2005

Treatment for diabetic foot ulcers.

People with diabetes develop foot ulcers because of neuropathy (sensory, motor, and autonomic deficits), ischaemia, or both. The initiating injury may be from acute mechanical or thermal trauma or from repetitively or continuously applied mechanical stress. Patients with clinically significant limb ischaemia should be assessed by a vascular surgeon to determine the need for angioplasty, stenting, or femorodistal bypass. When infection complicates a foot ulcer, the combination can be limb or life-threatening. Infection is defined clinically, but wound cultures reveal the causative pathogens. Tissue specimens are strongly preferred to wound swabs for wound cultures. Antimicrobial therapy should be guided by culture results, and should aim to cure the infection, not to heal the wound. Alleviation of the mechanical load on ulcers (off-loading) should always be a part of treatment. Neuropathic ulcers typically heal in 6 weeks with total contact casting, because it effectively relieves pressure at the ulcer site and enforces patient compliance. The success of other approaches to off-loading similarly depends on the patients' adherence to the effectiveness of pressure relief. Surgery to heal ulcers and prevent recurrence can include tenotomy, tendon lengthening, reconstruction, or removal of bony prominences. However, these procedures may result in secondary ulceration and other complications. Ulcer recurrence rates are high, but appropriate education for patients, the provision of posthealing footwear, and regular foot care can reduce rates of re-ulceration.

Amputation, Surgical↗
PubMed2005

Daptomycin for treating infected diabetic foot ulcers: evidence from a randomized, controlled trial comparing daptomycin with vancomycin or semi-synthetic penicillins for complicated skin and skin-structure infections.

OBJECTIVES: The predominant pathogens causing diabetic foot infections are Gram-positive cocci, many of which are now resistant to commonly prescribed antibiotics. Daptomycin is a new agent that is active against most Gram-positive pathogens. To compare the effectiveness of daptomycin against semi-synthetic penicillins or vancomycin, we analysed the subset of diabetic patients with an infected ulcer enrolled in two randomized, controlled investigator-blind trials of patients with complicated skin and soft-tissue infections presumptively caused by Gram-positive organisms. PATIENTS AND METHODS: Patients with a diabetic ulcer infection were prospectively stratified to ensure they were equally represented in the treatment groups, then randomized to either daptomycin [4 mg/kg every 24 h intravenously (iv)] or a pre-selected comparator (vancomycin or a semi-synthetic penicillin) for 7-14 days. RESULTS: Among 133 patients with a diabetic ulcer infection, 103 were clinically evaluable; 47 received daptomycin and 56 received a comparator. Most infections were monomicrobial, and Staphylococcus aureus was the predominant pathogen. Success rates for patients treated with daptomycin or the comparators were not statistically different for clinical (66% versus 70%, respectively; 95% CI, -14.4, 21.8) or microbiological (overall or by pathogen) outcomes. Both treatments were generally well tolerated, with most adverse events of mild to moderate severity. CONCLUSIONS: The clinical and microbiological efficacy and safety of daptomycin were similar to those of commonly used comparator antibiotics for treating infected diabetic foot ulcers caused by Gram-positive pathogens. Daptomycin should be considered for treating these infections, especially those caused by resistant Gram-positive pathogens.

Adolescent↗
PubMed2005

Preventing foot ulcers in patients with diabetes.

CONTEXT: Among persons diagnosed as having diabetes mellitus, the prevalence of foot ulcers is 4% to 10%, the annual population-based incidence is 1.0% to 4.1%, and the lifetime incidence may be as high as 25%. These ulcers frequently become infected, cause great morbidity, engender considerable financial costs, and are the usual first step to lower extremity amputation. OBJECTIVE: To systematically review the evidence on the efficacy of methods advocated for preventing diabetic foot ulcers in the primary care setting. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION: The EBSCO, MEDLINE, and the National Guideline Clearinghouse databases were searched for articles published between January 1980 and April 2004 using database-specific keywords. Bibliographies of retrieved articles were also searched, along with the Cochrane Library and relevant Web sites. We reviewed the retrieved literature for pertinent information, paying particular attention to prospective cohort studies and randomized clinical trials. DATA SYNTHESIS: Prevention of diabetic foot ulcers begins with screening for loss of protective sensation, which is best accomplished in the primary care setting with a brief history and the Semmes-Weinstein monofilament. Specialist clinics may quantify neuropathy with biothesiometry, measure plantar foot pressure, and assess lower extremity vascular status with Doppler ultrasound and ankle-brachial blood pressure indices. These measurements, in conjunction with other findings from the history and physical examination, enable clinicians to stratify patients based on risk and to determine the type of intervention. Educating patients about proper foot care and periodic foot examinations are effective interventions to prevent ulceration. Other possibly effective clinical interventions include optimizing glycemic control, smoking cessation, intensive podiatric care, debridement of calluses, and certain types of prophylactic foot surgery. The value of various types of prescription footwear for ulcer prevention is not clear. CONCLUSIONS: Substantial evidence supports screening all patients with diabetes to identify those at risk for foot ulceration. These patients might benefit from certain prophylactic interventions, including patient education, prescription footwear, intensive podiatric care, and evaluation for surgical interventions.

Cost-Benefit Analysis↗
PubMed2005

Antibiotic treatment of osteomyelitis: what have we learned from 30 years of clinical trials?

OBJECTIVES AND DESIGN: To determine the most appropriate approach to antibiotic therapy for osteomyelitis, the medical literature for articles published from 1968 to 2000 was reviewed. RESULTS: Ninety-three clinical trials in children and adults were identified using almost every antibiotic class. Most studies were non-comparative and the comparative trials involved relatively few patients. Publications generally did not provide clinically important information regarding infection staging or classification, surgical treatment provided, or the presence of orthopedic hardware. The median duration of follow-up after treatment was only 12 months. The clinical outcome was better for acute than chronic osteomyelitis in eight of the 12 studies allowing comparison. In the comparative trials, few statistically significant differences were observed between the tested treatments. In one small trial, the combination of nafcillin plus rifampin was more effective than nafcillin alone. In pediatric osteomyelitis, oral therapy with cloxacillin was more effective than tetracycline in one study, and oral clindamycin was as effective as parenteral anti-staphylococcal penicillins in another. In several investigations oral fluoroquinolones were as effective as standard parenteral treatments. CONCLUSIONS: Although the optimal duration of antibiotic therapy remains undefined, most investigators treated patients for about six weeks. Despite three decades of research, the available literature on the treatment of osteomyelitis is inadequate to determine the best agent(s), route, or duration of antibiotic therapy.

Anti-Bacterial Agents↗
PubMed2005

Are granulocyte colony-stimulating factors beneficial in treating diabetic foot infections?: A meta-analysis.

OBJECTIVE: To assess the value of granulocyte colony-stimulating factor (G-CSF) as adjunctive therapy for diabetic foot infections. RESEARCH DESIGN AND METHODS: We systematically searched the medical literature (including Medline, Embase, LookSmart, and the Cochrane Library) for prospective randomized studies that used G-CSF as an adjunct to standard treatment for diabetic foot infections. Using a conventional meta-analysis, we pooled the relative risks (RRs) for outcomes of interest, including resolution of infection, wound healing, duration of antibiotic therapy, and need for various surgical interventions, using a fixed-effects model. RESULTS: Five randomized trials, with a total of 167 patients, met our inclusion criteria. The methodological quality of the studies was satisfactory. The investigators administered various G-CSF preparations parenterally for between 3 and 21 days. The meta-analysis revealed that adding G-CSF did not significantly affect the resolution of infection or the healing of the wounds but was associated with a significantly reduced likelihood of lower extremity surgical interventions (RR 0.38 [95% CI 0.20-0.69], number of patients who needed to be treated: 4.5), including amputation (0.41 [0.17-0.95], number of patients who needed to be treated: 8.6). There was no evidence of heterogeneity among the studies or of publication bias, suggesting that these conclusions are reasonably generalizable and robust. CONCLUSIONS: Adjunctive G-CSF treatment does not appear to hasten the clinical resolution of diabetic foot infection or ulceration but is associated with a reduced rate of amputation and other surgical procedures. The small number of patients who needed to be treated to gain these benefits suggests that using G-CSF should be considered, especially in patients with limb-threatening infections.

Amputation, Surgical↗
PubMed2004

Use of maximal sterile barriers during central venous catheter insertion: clinical and economic outcomes.

BACKGROUND: We performed a cost-effectiveness analysis to determine the effect of maximal sterile barriers (MSBs) on reducing central venous catheter (CVC)--related infections. Use of MSBs when placing CVCs may reduce the risk of infections but is more cumbersome, time-consuming, and expensive than other techniques. METHODS: We developed a decision analytic model in which a patient could have a CVC placed with either an MSB or a less stringent technique. We calculated total direct medical costs and the incidences of catheter-related bloodstream infections, catheter colonization, and death. RESULTS: Use of MSBs lowered costs (from 621 dollars to 369 dollars per catheter insertion) and decreased the incidences of catheter-related bloodstream infections (from 5.3% to 2.8%), catheter colonization with local infection (from 5.5% to 2.9%) and death (from 0.8% to 0.4%). MSBs improved patient safety throughout all sensitivity analyses. CONCLUSIONS: Use of MSBs during CVC insertion likely lowers medical costs and decreases the incidences of catheter colonization, catheter-related bloodstream infections, and death. Cost savings were found over a wide range of clinical and economic assumptions, suggesting that MSBs should be routinely used when CVCs are inserted.

Catheterization, Central Venous↗
PubMed2004

Medical treatment of diabetic foot infections.

Diabetic foot infections frequently cause morbidity, hospitalization, and amputations. Gram-positive cocci, especially staphylococci and also streptococci, are the predominant pathogens. Chronic or previously treated wounds often yield several microbes on culture, including gram-negative bacilli and anaerobes. Optimal culture specimens are wound tissue taken after debridement. Infection of a wound is defined clinically by the presence of purulent discharge or inflammation; systemic signs and symptoms are often lacking. Only infected wounds require antibiotic therapy, and the agents, route, and duration are predicated on the severity of infection. Mild to moderate infections can usually be treated in the outpatient setting with oral agents; severe infections require hospitalization and parenteral therapy. Empirical therapy must cover gram-positive cocci and should be broad spectrum for severe infections. Definitive therapy depends on culture results and the clinical response. Bone infection is particularly difficult to treat and often requires surgery. Several adjuvant agents may be beneficial in some cases.

Diabetic Foot↗
PubMed2004

Controversies in diagnosing and managing osteomyelitis of the foot in diabetes.

The optimal approach to diagnosing and managing osteomyelitis of the foot in diabetes is unclear. Diagnosis is based on clinical signs, supplemented by a variety of imaging tests. Bone biopsy is the accepted criterion standard for diagnosis but is not used by many. Management traditionally involves surgical removal of infected bone, combined with antibiotic therapy. However, recent studies have shown that antibiotics alone may apparently eliminate bone infection in many cases. There is also evidence that early amputation of infected digits is frequently noncurative. Agreement on criteria for diagnosing osteomyelitis is required, and randomized trials are urgently needed, to determine the relative benefits of various surgical interventions and the optimal deployment of antibiotics. We review the microbiology of osteomyelitis of the foot in diabetes, the benefits and limitations of various diagnostic procedures, and the evidence for the effectiveness of both surgical and nonsurgical approaches to management.

Clinical Trials as Topic↗
PubMed2004

Using maximal sterile barriers to prevent central venous catheter-related infection: a systematic evidence-based review.

BACKGROUND: Catheter-related infections cause increased morbidity, mortality, and health care costs. Infection control experts advocate using maximal sterile barriers to reduce the incidence of these infections. Low compliance rates suggest that clinicians are not convinced or are not aware that available data support adopting this more cumbersome, time-consuming, and relatively more expensive technique. Accordingly, we conducted a systematic, evidence-based review of the medical literature to determine the value of maximal sterile barriers. DATA SOURCES: We used multiple computerized databases, reference lists of identified articles, and queries of prominent investigators. STUDY SELECTION: We selected studies comparing infectious outcomes using maximal sterile barriers versus using less stringent sterile barrier techniques during central venous catheter insertion. DATA SYNTHESIS: We found only 3 primary research studies. Although each study suggests maximal sterile barriers may reduce infectious complications, the evidence supporting this conclusion is incomplete. The only randomized controlled trial limited enrollment to ambulatory oncology patients. These 3 studies differed notably in their patient populations, research designs, and health care settings. CONCLUSION: The medical literature suggests maximal sterile barriers are advantageous in at least one setting and may be useful in others. While we believe the available evidence does support the use of maximal sterile barriers during routine insertion of central venous catheters, prospective studies and economic analyses would better clarify its value.

Bacteremia↗
PubMed2004

Advances in the treatment of diabetic foot infections.

Lower extremity infections are frequent causes of substantial morbidity and mortality in the diabetic population, and these infections consume a large portion of resources expended on diabetic complications. Gram-positive cocci, particularly Staphylococcus aureus, are the most important pathogens in diabetic foot infections. These organisms are predominant both in mild infections (which are often monomicrobial), as well as in more severe and chronic infected wounds that more often have a polymicrobial cause. Appropriate clinical assessment and culturing of infections are critical in establishing the presence and severity of infection, in detecting osteomyelitis, and in directing the optimal treatment approach. Following necessary debridement and other surgical interventions (e.g., bone resection, revascularization), appropriate antibiotic therapy is a cornerstone of managing the infected lower extremity. Peripheral vascular (i.e., arterial) insufficiency and the increasing prevalence of antibiotic resistance are primary barriers to successfully managing these infections. Fortunately, alternative delivery systems (e.g., antibiotic beads, impregnated sponges) and novel antibiotics (e.g., levofloxacin, linezolid) are providing possible solutions to the challenges posed by this physically, emotionally, and financially devastating condition.

Anti-Bacterial Agents↗
PubMed2004

Complicated infections of skin and skin structures: when the infection is more than skin deep.

Skin and skin-structure infections are common, and range from minor pyodermas to severe necrotizing infections. Complicated infections are defined as involving abnormal skin or wounds, occurring in compromised hosts, or requiring surgical intervention. Classification schemes for these infections are varied and confusing. Distinguishing characteristics include the aetiological agent(s), clinical context and findings, depth of tissue involvement and rate of progression. The most common pathogens are aerobic Gram-positive cocci, but complicated infections frequently involve Gram-negative bacilli and anaerobic bacteria. Initial antibiotic therapy is usually empirical, and later modified by the results of stains and cultures of wound specimens. Broad-spectrum coverage is frequently needed for complicated infections. Ertapenem is a once-a-day parenteral Group 1 carbapenem antibiotic, recently licensed in the USA and Europe, which may assume an important role in treating some complicated skin and skin-structure infections. Surgical debridement is important for many complicated infections, and is the critical element in managing necrotizing fasciitis and myonecrosis.

Adult↗
PubMed2003

Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate.

Foot infections in diabetic patients are predominantly caused by gram-positive cocci, many of which are now antibiotic resistant. Because linezolid is active against these pathogens, we compared the efficacy and safety of intravenous and oral formulations with that of intravenous ampicillin-sulbactam and intravenous and oral amoxicillin-clavulanate given for 7-28 days in a randomized, open-label, multicenter study of all types of foot infection in diabetic patients (ratio of linezolid to comparator drug recipients, 2:1). Among 371 patients, the clinical cure rates associated with linezolid and the comparators were statistically equivalent overall (81% vs. 71%, respectively) but were significantly higher for linezolid-treated patients with infected foot ulcers (81% vs. 68%; P=.018) and for patients without osteomyelitis (87% vs. 72%; P=.003). Cure rates were comparable for inpatients and outpatients and for both oral and intravenous formulations. Drug-related adverse events were significantly more common in the linezolid group, but they were generally mild and reversible. Linezolid was at least as effective as aminopenicillin/beta-lactamase inhibitors for treating foot infections in diabetic patients.

Acetamides↗
PubMed2003

Vascular catheter site care: the clinical and economic benefits of chlorhexidine gluconate compared with povidone iodine.

The use of chlorhexidine gluconate solution for vascular catheter insertion site care reduces the risk of catheter-related bloodstream infection by one-half, compared with povidone iodine. Our objective was to evaluate the cost-effectiveness of chlorhexidine gluconate versus povidone iodine. We used data from randomized, controlled trials, meta-analyses, and epidemiologic studies to construct a decision analysis model. We estimated that use of chlorhexidine, rather than povidone, for central catheter site care resulted in a 1.6% decrease in the incidence of catheter-related bloodstream infection, a 0.23% decrease in the incidence of death, and savings of 113 dollars per catheter used. For peripheral catheter site care, the results were similar, although the differences were smaller. The results were found to be robust on multivariate sensitivity analyses. Use of chlorhexidine gluconate in place of the current standard solution for vascular catheter site care is a simple and cost-effective method of improving patient safety in the hospital setting.

Anti-Infective Agents, Local↗