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Biomedical subjects

Kent A Sepkowitz

Publications and source records attributed to Kent A Sepkowitz.

At least 19 recordsLinked to original sources
PubMed2006

Issues related to the design and interpretation of clinical trials of salvage therapy for invasive mold infection.

Invasive mold infection is a major cause of morbidity and mortality among severely immunocompromised individuals. We discuss the challenges involved in the design and interpretation of salvage antifungal trials, focusing on mold infection. We suggest that patients with refractory fungal infection be analyzed separately from those with intolerance to standard regimens because of the poorer prognosis of the former group. We propose a composite outcome assessment in which refractory infection is defined as infection associated with the worsening of at least 2 of the following 3 types of criteria: clinical, radiologic, and mycologic. Confounding variables, including heterogeneity in host factors, initial antifungal therapy, and selection bias, are discussed. Although randomized studies would provide the most credible results, the lack of an adequate number of patients to meet prespecified stratification criteria for all confounding variables makes such studies impractical. Given that randomized studies are unrealistic, studies involving carefully selected, matched, contemporaneous control subjects are likely to be the most useful alternative.

Antifungal Agents↗
PubMed2006

Progression of Pneumocystis jiroveci pneumonia in patients receiving echinocandin therapy.

Echinocandins are a novel class of antifungal drugs that target beta (1, 3)-D-glucan synthesis. Animal studies have shown that these agents have activity against Pneumocystis jiroveci infection; however, clinical data are lacking. We reviewed all cases of proven P. jiroveci pneumonia (PCP) in non-human immunodeficiency virus-infected patients at our hospital over a 5 year period (2001-2005). Two patients received conventional PCP treatment and concomitant use of echinocandins for presumed invasive aspergillus. In both cases, PCP progressed, and the patient died. The use of echinocandins in the prevention or treatment of PCP cannot be recommended without evidence to support their effectiveness.

Adolescent↗
PubMed2006

A multicenter intervention to prevent catheter-associated bloodstream infections.

BACKGROUND: Education-based interventions can reduce the incidence of catheter-associated bloodstream infection. The generalizability of findings from single-center studies is limited. OBJECTIVE: To assess the effect of a multicenter intervention to prevent catheter-associated bloodstream infections. DESIGN: An observational study with a planned intervention. SETTING: Twelve intensive care units and 1 bone marrow transplantation unit at 6 academic medical centers. PATIENTS: Patients admitted during the study period. INTERVENTION: Updates of written policies, distribution of a 9-page self-study module with accompanying pretest and posttest, didactic lectures, and incorporation into practice of evidence-based guidelines regarding central venous catheter (CVC) insertion and care. MEASUREMENTS: Standard data collection tools and definitions were used to measure the process of care (ie, the proportion of nontunneled catheters inserted into the femoral vein and the condition of the CVC insertion site dressing for both tunneled and nontunneled catheters) and the incidence of catheter-associated bloodstream infection. RESULTS: Between the preintervention period and the postintervention period, the percentage of CVCs inserted into the femoral vein decreased from 12.9% to 9.4% (relative ratio, 0.73; 95% confidence interval [CI], 0.61-0.88); the total proportion of catheter insertion site dressings properly dated increased from 26.6% to 34.4% (relative ratio, 1.29; 95% CI, 1.17-1.42), and the overall rate of catheter-associated bloodstream infections decreased from 11.2 to 8.9 infections per 1,000 catheter-days (relative rate, 0.79; 95% CI, 0.67-0.93). The effect of the intervention varied among individual units. CONCLUSIONS: An education-based intervention that uses evidence-based practices can be successfully implemented in a diverse group of medical and surgical units and reduce catheter-associated bloodstream infection rates.

Academic Medical Centers↗
PubMed2006

The risk of tuberculosis in patients with cancer.

Current US guidelines for the management of latent tuberculosis infection in cancer patients are based on studies from 1970s, yet much about cancer care has changed in the interim. In a review of our experience during the past 25 years, we found that incidence of tuberculosis varied significantly according to country of birth and cancer type. Foreign-born patients with underlying hematologic neoplasm had a tuberculosis rate 50-100 times higher than US-born patients, whereas US-born patients with an underlying solid tumor had the same tuberculosis rate as US-born persons without cancer. These findings may help guide the management of latent tuberculosis infection in persons with cancer.

Adolescent↗
PubMed2006

Efficacy of safety-engineered device implementation in the prevention of percutaneous injuries: a review of published studies.

Nearly 6 years have passed since the Needlestick Safety and Prevention Act of 2000 was signed into law. We reviewed studies published since 1995 that evaluated the effect of safety-engineered device implementation on rates of percutaneous injury (PI) among health care workers. Criteria for inclusion of studies in the review were as follows: the intervention used to reduce PIs was a needleless system or a device with engineered sharps-injury protection, the outcome measurements included a PI rate, the intervention was evaluated in a defined population with clear comparison groups in clinical settings, and outcomes and denominators used for rate calculations were objectively measured using consistent methodology. All 17 studies reported substantial decreases in device-associated or overall PI rates after device implementation (range of reduction, 22%-100%). The majority of studies (n=12) were uncontrolled before-after trials with limited ability to control for confounding variables. In addition, implementation of safety-engineered devices was often accompanied by other interventions, and direct measurement of outcomes was not performed. Nevertheless, safety-engineered devices are an important component in PI prevention.

Equipment Safety↗
PubMed2005

Treatment of patients with hematologic neoplasm, fever, and neutropenia.

Choices of empirical antibiotic therapy for patients with febrile neutropenia must be made with very little information about the source and site of infection. The clinician is aided by recognition of the subtle signs and symptoms of infection in immunocompromised patients. National guidelines should be applied according to the microbiological patterns and trends in drug resistance at each institution. Case studies are provided to illustrate these challenges in daily practice.

Adult↗
PubMed2005

Varying rates of Clostridium difficile-associated diarrhea at prevention epicenter hospitals.

BACKGROUND: Clostridium difficile-associated diarrhea (CDAD) causes substantial healthcare-associated morbidity. Unlike other common healthcare-associated pathogens, little comparative information is available about CDAD rates in hospitalized patients. OBJECTIVES: To determine CDAD rates per 10,000 patient-days and per 1,000 hospital admissions at 7 geographically diverse tertiary-care centers from 2000 to 2003, and to survey participating centers on methods of CDAD surveillance and case definition. METHODS: Each center provided specific information for the study period, including case numbers, patient-days, and hospital characteristics. Case definitions and laboratory diagnoses of healthcare-associated CDAD were determined by each institution. Within institutions, case definitions remained consistent during the study period. RESULTS: Overall, mean annual case rates of CDAD were 12.1 per 10,000 patient-days (range, 3.1 to 25.1) and 7.4 per 1,000 hospital admissions (range, 3.1 to 13.1). No significant increases were observed in CDAD case rates during the 4-year interval, either at individual centers or in the Prevention Epicenter hospitals as a whole. Prevention Epicenter hospitals differed in their CDAD case definitions. Different case definitions used by the hospitals applied to a fixed data set resulted in a 30% difference in rates. No associations were identified between diagnostic test or case definition used and the relative rate of CDAD at a specific medical center. CONCLUSIONS: Rates of CDAD vary widely at tertiary-care centers across the United States. No significant increases in case rates were identified. The varying clinical and laboratory approaches to diagnosis complicated comparisons between hospitals. To facilitate benchmarking and comparisons between institutions, we recommend development of a more standardized case definition.

Clostridioides difficile↗
PubMed2005

Risk factors for acquisition of Clostridium difficile-associated diarrhea among outpatients at a cancer hospital.

BACKGROUND: Clostridium difficile-associated diarrhea (CDAD) is an important infection in hospital settings. Its impact on outpatient care has not been well defined. OBJECTIVE: To examine risk factors of ambulatory cancer patients with CDAD. DESIGN: Case-control study. SETTING: Memorial Sloan-Kettering Cancer Center, a tertiary-care hospital. METHODS: Cases of CDAD among oncology outpatients from January 1999 through December 2000 were'identified via positive C. difficile toxin assay results on stool specimens sent from clinics or the emergency department. A 1:3 matched case-control study examined exposures associated with CDAD. RESULTS: Forty-eight episodes of CDAD were identified in cancer outpatients. The mean age was 51 years; 44% were female. Forty-one (85%) had received antibiotics within 60 days of diagnosis, completing courses a median of 16.5 days prior to diagnosis. Case-patients received longer courses of first-generation cephalosporins (4.8 vs 3.2 days; P = .03) and fluoroquinolones (23.6 vs 8 days; P < .01) than did control-patients. Those receiving clindamycin were 3.9-fold more likely to develop CDAD (P < .01). For each additional day of clindamycin or third-generation cephalosporin exposure, patients were 1.29- and 1.26-fold more likely to develop CDAD (P < .01 and .04, respectively). The 38 CDAD patients hospitalized during the risk period (79.2%) spent more time as inpatients than did control-patients (19.3 vs 9.7 days; P < .001). CONCLUSIONS: Antibiotic use, especially with cephalosporins and clindamycin, and prolonged hospitalization contributed to the development of CDAD. Outpatient CDAD appears to be most strongly related to inpatient exposures; reasons for the delayed development of symptoms are unknown.

Adult↗
PubMed2005

Occupational deaths among healthcare workers.

Recent experiences with severe acute respiratory syndrome and the US smallpox vaccination program have demonstrated the vulnerability of healthcare workers to occupationally acquired infectious diseases. However, despite acknowledgment of risk, the occupational death rate for healthcare workers is unknown. In contrast, the death rate for other professions with occupational risk, such as police officer or firefighter, has been well defined. With available information from federal sources and calculating the additional number of deaths from infection by using data on prevalence and natural history, we estimate the annual death rate for healthcare workers from occupational events, including infection, is 17-57 per 1 million workers. However, a much more accurate estimate of risk is needed. Such information could inform future interventions, as was seen with the introduction of safer needle products. This information would also heighten public awareness of this often minimized but essential aspect of patient care.

HIV Infections↗
PubMed2004

Selective CD4+ lymphopenia in melanoma patients treated with temozolomide: a toxicity with therapeutic implications.

PURPOSE: Standard schedule temozolomide (TMZ; daily for 5 days every 4 weeks) is often used in melanoma patients, but phase III data show that it is no more effective than standard dacarbazine. Extended TMZ dosing regimens may be superior by delivering the drug continuously at a higher dose over time. Using an extended dosing schedule, we noted a high incidence of lymphopenia and occasional opportunistic infections (OIs). Here we report our retrospective experience in the first 97 patients. MATERIALS AND METHODS: TMZ was administered at 75 mg/m(2)/d orally for 6 weeks every 8 weeks, although nine patients were treated continuously without a break. Seventeen patients were treated with TMZ alone; 73 patients received TMZ with thalidomide; seven patients received TMZ with low-dose interferon alfa. RESULTS: Median duration of TMZ treatment was 113 days; 29% received > or = 24 weeks of therapy. Lymphopenia was seen in 60% of patients (absolute lymphocyte count < 800/microL) with a median of 101 days to lymphopenia. TMZ did not cause significant neutropenia or thrombocytopenia. Lymphopenia was not more common in patients treated concomitantly with thalidomide. In all patients analyzed for lymphocyte subsets, lymphopenia induced by TMZ affected the CD4(+) compartment preferentially. There were two documented OIs (Pneumocystis and Aspergillus pneumonia) as well as other infections indicative of T-cell dysfunction in another 21 patients. CONCLUSION: TMZ at this dose and schedule results in CD4(+) lymphopenia in a majority of patients that can result in OIs. Pneumocystis pneumonia prophylaxis should be considered for patients who develop sustained lymphopenia on TMZ.

Adult↗
PubMed2004

Effect of implementing safety-engineered devices on percutaneous injury epidemiology.

OBJECTIVE: To assess the effect of implementing safety-engineered devices on percutaneous injury epidemiology, specifically on percutaneous injuries associated with a higher risk of blood-borne pathogen exposure. DESIGN: Before-and-after intervention trial comparing 3-year preintervention (1998--2000) and 1-year postintervention (2001--2002) periods. Percutaneous injury data have been entered prospectively into CDC NaSH software since 1998. SETTING: A 427-bed, tertiary-care hospital in Manhattan. PARTICIPANTS: All employees who reported percutaneous injuries during the study period. INTERVENTION: A "safer-needle system," composed of a variety of safety-engineered devices to allow for needle-safe IV delivery, blood collection, IV insertion, and intramuscular and subcutaneous injection, was implemented in February 2001. RESULTS: The mean annual incidence of percutaneous injuries decreased from 34.08 per 1,000 full-time-equivalent employees preintervention to 14.25 postintervention (P < .001). Reductions in the average monthly number of percutaneous injuries resulting from both low-risk (P < .01) and high-risk (P was not significant) activities were observed. Nurses experienced the greatest decrease (74.5%, P < .001), followed by ancillary staff (61.5%, P = .03). Significant rate reductions were observed for the following activities: manipulating patients or sharps (83.5%, P < .001), collisions or contact with sharps (73.0%, P = .01), disposal-related injuries (21.41%, P = .001), and catheter insertions (88.2%, P < .001). Injury rates involving hollow-bore needles also decreased (70.6%, P < .001). CONCLUSIONS: The implementation of safety-engineered devices reduced percutaneous injury rates across occupations, activities, times of injury, and devices. Moreover, intervention impact was observed when stratified by risk for blood-borne pathogen transmission.

Equipment Design↗
PubMed2004

Safety-engineered device implementation: does it introduce bias in percutaneous injury reporting?

OBJECTIVE: To examine whether implementation of safety-engineered devices in 2001 had an effect on rates of percutaneous injury (PI) reported by HCWs. DESIGN: Before-and-after intervention trial comparing 3-year preintervention (1998--2001) and 2-year postintervention (2001--2002) periods. PI data from anonymous, self-administered surveys were prospectively entered into CDC NaSH software. SETTING: A 427-bed, tertiary-care hospital in Manhattan. PARTICIPANTS: HCWs who attended state-mandated training sessions and completed the survey (1,132 preintervention; 821 postintervention). INTERVENTION: Implementation of a "safer-needle system" composed of various safety-engineered devices for needle-safe IV delivery-insertion, blood collection, and intramuscular-subcutaneous injection. RESULTS: Preintervention, the overall annual rate of PIs self-reported on the survey was 36.5 per 100 respondents, compared with 13.9 per 100 respondents postintervention (P < .01). The annual rate of formally reported PIs decreased from 8.3 to 3.1 per 100 respondents (P < .01). Report rates varied by occupational group (P < or = .02). The overall rate did not change between study periods (22.7% to 22.3%), although reporting improved among nurses (23.6% to 44.4%, P = .03) and worsened among building services staff (90.5% to 50%, P = .03). HCWs with greater numbers of PIs self-reported on the survey were less likely to formally report injuries (P < .01). The two most common reasons for nonreport (ie, thought injury was low risk or believed patient was low risk for blood-borne disease) did not vary from preintervention to postintervention. CONCLUSIONS: Safety-engineered device implementation decreased rates of PIs formally reported and self-reported on the survey. However, this intervention, with concomitant intensive education, had varying effects on reporting behavior by occupation and a minimal effect on overall reporting rates.

Bias↗
PubMed2004

Risk to cancer patients from nosocomial hepatitis C virus.

Nosocomial transmission of hepatitis C virus (HCV) among dialysis patients is a well-described phenomenon. In addition, spread of HCV in outpatient medical clinic settings has recently been reported. In the past decade, nosocomial spread of hepatitis C among hospitalized patients being treated for cancer has increasingly been reported. The cause or source of transmission is unknown. Infection control practitioners should be aware of this potential risk to oncology patients.

Comorbidity↗