Mindy Marie Sampson

All Publications

• Clinical decision support in the electronic health record: a primer for antimicrobial stewards and infection preventionists: work smarter so end users don't work harder. Antimicrobial stewardship & healthcare epidemiology : ASHE Smith, M. R., Lee, J. J., Holubar, M., Salinas, J. L., Sampson, M. M., Medford, R. J., Chang, A. 2024; 4 (1): e204

  Abstract

  Computerized clinical decision support (CDS) assists healthcare professionals in making decisions to improve patient care. In the realms of antimicrobial stewardship (ASP) and infection prevention (IP) programs, CDS interventions can play a crucial role in optimizing antibiotic prescribing practices, reducing healthcare-associated infections, and promoting diagnostic stewardship when optimally designed. This primer article aims to provide ASP and IP professionals with a practical framework for the development, design, and evaluation of CDS interventions.Large academic medical center design: Established frameworks of CDS evaluation, "Five Rights" of CDS and the "Ten Commandments of Effective Clinical Decision Support", were applied to two real-world examples of CDS tools, a Vancomycin Best Practice Advisory and a Clostridioides Difficile order panel, to demonstrate a structured approach to developing and enhancing the functionality of ASP/IP CDS interventions to promote efficacy and reduce unintended consequences of CDS.By outlining a structured approach for the development and evaluation of CDS interventions, with focus on end user engagement, efficiency and feasibility, ASP and IP professionals can leverage CDS to enhance IP/ASP quality improvement initiatives aimed to improve antibiotic utilization, diagnostic stewardship, and adherence to IP protocols.

  View details for DOI 10.1017/ash.2024.448

  View details for PubMedID 39563933

  View details for PubMedCentralID PMC11574583

• Racial disparities in central line-associated bloodstream infections: the impact of the COVID-19 pandemic. Infection control and hospital epidemiology DeWitt, M. E., Sampson, M. M., Kester, S., MacNeill, E., Passaretti, C. 2024: 1-5

  Abstract

  This retrospective cohort study analyzed differences in rates of central line-associated bloodstream infections (CLABSI) in Black and White inpatients across 11 southeastern US hospitals from 2019 to 2021. Results showed higher CLABSI rates in Black patients during the coronavirus disease 2019 (COVID-19) pandemic, even after adjustment for COVID-19 infection and clinical factors.

  View details for DOI 10.1017/ice.2024.147

  View details for PubMedID 39323352

• Beyond the surface: a color-inclusive guide to central line site assessment. Antimicrobial stewardship & healthcare epidemiology : ASHE Herrera, M., Eichenblat, S., Campbell, E., Shick, J., Brown, H., Brinkley, C., Kester, S., Layell, J., Passaretti, C. L., Sampson, M. M. 2024; 4 (1): e41

  Abstract

  Significant gaps exist in representation of diverse populations in central-line assessment education and tools. We review some of these gaps and provide some real-world guidance on how to assess central line sites in patients of all skin tones.

  View details for DOI 10.1017/ash.2024.39

  View details for PubMedID 38628376

  View details for PubMedCentralID PMC11019580

• Syphilis Treatment: Systematic Review and Meta-Analysis Investigating Nonpenicillin Therapeutic Strategies. Open forum infectious diseases Callado, G. Y., Gutfreund, M. C., Pardo, I., Hsieh, M. K., Lin, V., Sampson, M. M., Nava, G. R., Marins, T. A., Deliberato, R. O., Martino, M. D., Holubar, M., Salinas, J. L., Marra, A. R. 2024; 11 (4): ofae142

  Abstract

  Background: Penicillin's long-standing role as the reference standard in syphilis treatment has led to global reliance. However, this dependence presents challenges, prompting the need for alternative strategies. We performed a systematic literature review and meta-analysis to evaluate the efficacy of these alternative treatments against nonneurological syphilis.Methods: We searched MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, Embase, Cochrane, Scopus, and Web of Science from database inception to 28 August 2023, and we included studies that compared penicillin or amoxicillin monotherapy to other treatments for the management of nonneurological syphilis. Our primary outcome was serological cure rates. Random-effect models were used to obtain pooled mean differences, and heterogeneity was assessed using the I2 test.Results: Of 6478 screened studies, 27 met the inclusion criteria, summing 6710 patients. The studies were considerably homogeneous, and stratified analyses considering each alternative treatment separately revealed that penicillin monotherapy did not outperform ceftriaxone (pooled odds ratio, 1.66 [95% confidence interval, .97-2.84]; I2 = 0%), azithromycin (0.92; [.73-1.18]; I2 = 0%), or doxycycline (0.82 [.61-1.10]; I2 = 1%) monotherapies with respect to serological conversion.Conclusions: Alternative treatment strategies have serological cure rates equivalent to penicillin, potentially reducing global dependence on this antibiotic.

  View details for DOI 10.1093/ofid/ofae142

  View details for PubMedID 38595955

• C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 'LIVE-AIR' trial. Thorax Temesgen, Z., Kelley, C. F., Cerasoli, F., Kilcoyne, A., Chappell, D., Durrant, C., Ahmed, O., Chappell, G., Catterson, V., Polk, C., Badley, A., Marconi, V. C. 2023; 78 (6): 606-616

  Abstract

  COVID-19 severity is correlated with granulocyte macrophage colony-stimulating factor (GM-CSF) and C reactive protein (CRP) levels. In the phase three LIVE-AIR trial, lenzilumab an anti-GM-CSF monoclonal antibody, improved the likelihood of survival without ventilation (SWOV) in COVID-19, with the greatest effect in participants having baseline CRP below a median of 79 mg/L. Herein, the utility of baseline CRP to guide lenzilumab treatment was assessed.A subanalysis of the randomised, blinded, controlled, LIVE-AIR trial in which lenzilumab or placebo was administered on day 0 and participants were followed through Day 28.Hospitalised COVID-19 participants (N=520) with SpO2 ≤94% on room air or requiring supplemental oxygen but not invasive mechanical ventilation.Lenzilumab (1800 mg; three divided doses, q8h, within 24 hours) or placebo infusion alongside corticosteroid and remdesivir treatments.The primary endpoint was the time-to-event analysis difference in SWOV through day 28 between lenzilumab and placebo treatments, stratified by baseline CRP.SWOV was achieved in 152 (90%; 95% CI 85 to 94) lenzilumab and 144 (79%; 72 to 84) placebo-treated participants with baseline CRP <150 mg/L (HR: 2.54; 95% CI 1.46 to 4.41; p=0.0009) but not with CRP ≥150 mg/L (HR: 1.04; 95% CI 0.51 to 2.14; p=0.9058). A statistically significant interaction between CRP and lenzilumab treatment was observed (p=0.044). Grade ≥3 adverse events with lenzilumab were comparable to placebo in both CRP strata. No treatment-emergent serious adverse events were attributed to lenzilumab.Hospitalised hypoxemic patients with COVID-19 with baseline CRP <150 mg/L derived the greatest clinical benefit from treatment with lenzilumab.NCT04351152; ClinicalTrials.gov.

  View details for DOI 10.1136/thoraxjnl-2022-218744

  View details for PubMedID 35793833

  View details for PubMedCentralID PMC10314034

• Reply. Diseases of the colon and rectum Ramprasad, C., Mgbako, O., Sampson, M., Passaretti, C., Moshiree, B. 2023; 66 (6): e311

  View details for DOI 10.1097/DCR.0000000000002869

  View details for PubMedID 36940302

• Mpox (Monkeypox) Infection During Pregnancy. Obstetrics and gynecology Sampson, M. M., Magee, G., Schrader, E. A., Dantuluri, K. L., Bukhari, A., Passaretti, C., Temming, L., Leonard, M., Philips, J. B., Weinrib, D. 2023; 141 (5): 1007-1010

  Abstract

  An mpox (formerly "monkeypox") outbreak began in 2022, leading to infection in special populations, including pregnant individuals.We present a case of an individual who presented with a labial ulcer and subsequent papular rash at 31 weeks of gestation. She was diagnosed with mpox infection and was treated with tecovirimat. She had an uncomplicated induction of labor at 39 2/7 weeks of gestation and delivered a healthy neonate. The neonate had a positive immunoglobulin G test result for orthopoxvirus but did not have skin lesions or positive molecular test results suggestive of infection.Transplacental transmission of mpox is possible, but, in this case, the neonate did not have clinical findings suggestive of active or antenatal mpox infection. Treatment with tecovirimat in gestational cases of mpox may be beneficial.

  View details for DOI 10.1097/AOG.0000000000005170

  View details for PubMedID 36928418

• Evaluation of a health system's implementation of a monkeypox care model under the RE-AIM framework. Therapeutic advances in infectious disease Polk, C., Sampson, M., Fairman, R. T., DeWitt, M. E., Leonard, M., Neelakanta, A., Davidson, L., Roshdy, D., Branner, C., McCurdy, L., Ludden, T., Tapp, H., Passaretti, C. 2023; 10: 20499361231158463

  Abstract

  Emerging infectious diseases challenge healthcare systems to implement new models of care. We aim to evaluate the rapid implementation of a new care model for monkeypox in our health system.This is a retrospective case series evaluation under the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework of implementation of a testing and care model for monkeypox in a large, integrated health system.Atrium Health implemented education of providers, testing protocols, and management of potential monkeypox cases using electronic health record (EHR) data capabilities, telehealth, and collaboration between multiple disciplines. The first 4 weeks of care model implementation were evaluated under the RE-AIM framework.One hundred fifty-three patients were tested for monkeypox by 117 unique providers at urgent care, emergency departments, and infectious disease clinics in our healthcare system between 18 July 2022 and 14 August 2022. Fifty-eight monkeypox cases were identified, compared with 198 cases in the state during the time period, a disproportionate number compared with the health system service area, and 52 patients were assessed for need for tecovirimat treatment. The number of tests performed and providers sending tests increased during the study period.Implementation of a dedicated care model leveraging EHR data support, telehealth, and cross-disciplinary collaboration led to more effective identification and management of emerging infectious diseases and is important for public health.Impact of care model implementation on monkeypox New infectious diseases challenge health systems to implement new care practices. Our health system responded to this challenge by implementing a care model for education, testing, and clinical care of monkeypox patients. We analyzed results from implementing the model. We were able to identify a disproportionate number of monkeypox cases compared with the rest of our state by using our model to educate medical providers, encourage testing, and ensure patients had access to best disease care. Implementation of care models for testing and management of new diseases will improve patient care and public health.

  View details for DOI 10.1177/20499361231158463

  View details for PubMedID 36911268

  View details for PubMedCentralID PMC9996722

• Monkeypox testing delays: The need for drastic expansion of education and testing for monkeypox virus. Infection control and hospital epidemiology Sampson, M. M., Polk, C. M., Fairman, R. T., DeWitt, M. E., Leonard, M. K., Davidson, L., McCurdy, L., Passaretti, C. L. 2023; 44 (2): 348-349

  View details for DOI 10.1017/ice.2022.237

  View details for PubMedID 36102128

• Perianal and Rectal Lesions in the Monkeypox Outbreak: Diagnosis and Proposed Management. Diseases of the colon and rectum Ramprasad, C., Mgbako, O., Sampson, M., Passaretti, C., Moshiree, B. 2022; 65 (12): 1422-1424

  View details for DOI 10.1097/DCR.0000000000002590

  View details for PubMedID 36037261

• A case of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) reinfection within ninety days of primary infection in a healthcare worker. Infection control and hospital epidemiology Sampson, M. M., Reeves, K. D., Polk, C. M., Hawkins, G. A., Passaretti, C. L. 2022; 43 (12): 2002-2003

  View details for DOI 10.1017/ice.2022.42

  View details for PubMedID 35190005

  View details for PubMedCentralID PMC8914128

• Global monkeypox case hospitalisation rates: A rapid systematic review and meta-analysis. EClinicalMedicine DeWitt, M. E., Polk, C., Williamson, J., Shetty, A. K., Passaretti, C. L., McNeil, C. J., Fairman, R. T., Sampson, M. M., Dalton, C., Sanders, J. W. 2022; 54: 101710

  Abstract

  Estimates of the case hospitalization rate and case fatality rate when hospital care is available for monkeypox (MPX) infections have not been well defined. This rapid systematic review and meta-analysis aimed to estimate the case hospitalisation rate and case fatality rate where hospital care is available.We systematically searched PubMed, Embase, the Lancet Preprints, and MedRxiv for studies published between Jan 1, 1950 and Aug 2, 2022. We included documents which contained both the number of cases and associated hospitalisations of MPX infections. From eligible studies we extracted the country, the year of the study, the study design type, the clade of MPX, the participant characteristics, transmission type, any treatments used, number of cases (including suspected, probable, or laboratory confirmed diagnosis), number of hospitalizations, hospitalized patient outcomes, and case definition. Case hospitalization rate (CHR) was defined as the proportion of cases that were admitted to hospital care while case fatality rate (CFR) was defined as the proportion of cases that died. CHR and CFR were analysed in a fully Bayesian meta-analytic framework using random effects models, including sub-group analysis with heterogeneity assessed using I2.Of the 259 unique documents identified, 19 studies were eligible for inclusion. Included studies represented 7553 reported cases among which there were 555 hospitalizations. Of the 7540 cases for which outcomes were available, there were 15 recorded deaths. The median age of cases was 35 years (interquartile range 28-38, n = 2010) and primarily male (7339/7489, 98%) in studies where age or sex were available. Combined CHR was estimated to be 14.1% (95% credible interval, 7.5-25.0, I2 97.4%), with a high degree of heterogeneity. Further analysis by outbreak period indicates CHRs of 49.8% (28.2-74.0, I2 81.4%), 21.7% (7.2-52.1, I2 57.7%), and 5.8% (3.2-9.4, I2 92.4%) during the pre-2017, 2017-2021, and 2022 outbreaks, respectively, again with high levels of heterogeneity. CFR was estimated to be 0.03% (0.0-0.44, I2 99.9%), with evidence of large heterogeneity between the studies.There is limited data for MPX hospitalization rates in countries where MPX has been traditionally non-endemic until the current outbreak. Due to substantial heterogeneity, caution is needed when interpreting these findings. Health care organizations should be cognizant of the potential increase in healthcare utilization. Rapid identification of infection and use of appropriate therapies such as antivirals play a role reducing the CHR and associated CFR.None.

  View details for DOI 10.1016/j.eclinm.2022.101710

  View details for PubMedID 36345526

  View details for PubMedCentralID PMC9621693

• Severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infections occurring in healthcare workers after booster vaccination: A comparison of delta versus omicron variants. Antimicrobial stewardship & healthcare epidemiology : ASHE Reeves, K. D., Polk, C. M., Cox, L. A., Fairman, R. T., Hawkins, G. A., Passaretti, C. L., Sampson, M. M. 2022; 2 (1): e143

  Abstract

  In this study, we used genomic sequencing to identify variants of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) in healthcare workers with coronavirus disease 2019 (COVID-19) after receiving a booster vaccination. We compared symptoms, comorbidities, exposure risks, and vaccine history between the variants. Postbooster COVID-19 cases increased as the SARS-CoV-2 omicron variant predominated.

  View details for DOI 10.1017/ash.2022.239

  View details for PubMedID 36483394

  View details for PubMedCentralID PMC9726498

• Cholecystitis as a Possible Immunologic Consequence of COVID-19; Case Series from a Large Healthcare System. The American journal of the medical sciences Polk, C., Sampson, M. M., Jacobs, A., Kooken, B., Ludden, T., Passaretti, C. L., Leonard, M. 2022; 363 (5): 456-458

  View details for DOI 10.1016/j.amjms.2022.01.008

  View details for PubMedID 35085530

  View details for PubMedCentralID PMC8785331

• Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. The Lancet. Respiratory medicine Temesgen, Z., Burger, C. D., Baker, J., Polk, C., Libertin, C. R., Kelley, C. F., Marconi, V. C., Orenstein, R., Catterson, V. M., Aronstein, W. S., Durrant, C., Chappell, D., Ahmed, O., Chappell, G., Badley, A. D. 2022; 10 (3): 237-246

  Abstract

  The pathophysiology of COVID-19 includes immune-mediated hyperinflammation, which could potentially lead to respiratory failure and death. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is among cytokines that contribute to the inflammatory processes. Lenzilumab, a GM-CSF neutralising monoclonal antibody, was investigated in the LIVE-AIR trial to assess its efficacy and safety in treating COVID-19 beyond available treatments.In LIVE-AIR, a phase 3, randomised, double-blind, placebo-controlled trial, hospitalised adult patients with COVID-19 pneumonia not requiring invasive mechanical ventilation were recruited from 29 sites in the USA and Brazil and were randomly assigned (1:1) to receive three intravenous doses of lenzilumab (600 mg per dose) or placebo delivered 8 h apart. All patients received standard supportive care, including the use of remdesivir and corticosteroids. Patients were stratified at randomisation by age and disease severity. The primary endpoint was survival without invasive mechanical ventilation to day 28 in the modified intention-to-treat population (mITT), comprising all randomised participants who received at least one dose of study drug under the documented supervision of the principal investigator or sub-investigator. Adverse events were assessed in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT04351152, and is completed.Patients were enrolled from May 5, 2020, until Jan 27, 2021. 528 patients were screened, of whom 520 were randomly assigned and included in the intention-to-treat population. 479 of these patients (n=236, lenzilumab; n=243, placebo) were included in the mITT analysis for the primary outcome. Baseline demographics were similar between groups. 311 (65%) participants were males, mean age was 61 (SD 14) years at baseline, and median C-reactive protein concentration was 79 (IQR 41-137) mg/L. Steroids were administered to 449 (94%) patients and remdesivir to 347 (72%) patients; 331 (69%) patients received both treatments. Survival without invasive mechanical ventilation to day 28 was achieved in 198 (84%; 95% CI 79-89) participants in the lenzilumab group and in 190 (78%; 72-83) patients in the placebo group, and the likelihood of survival was greater with lenzilumab than placebo (hazard ratio 1·54; 95% CI 1·02-2·32; p=0·040). 68 (27%) of 255 patients in the lenzilumab group and 84 (33%) of 257 patients in the placebo group experienced at least one adverse event that was at least grade 3 in severity based on CTCAE criteria. The most common treatment-emergent adverse events of grade 3 or higher were related to respiratory disorders (26%) and cardiac disorders (6%) and none led to death.Lenzilumab significantly improved survival without invasive mechanical ventilation in hospitalised patients with COVID-19, with a safety profile similar to that of placebo. The added value of lenzilumab beyond other immunomodulators used to treat COVID-19 alongside steroids remains unknown.Humanigen.

  View details for DOI 10.1016/S2213-2600(21)00494-X

  View details for PubMedID 34863332

  View details for PubMedCentralID PMC8635458

• Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA O'Brien, M. P., Forleo-Neto, E., Sarkar, N., Isa, F., Hou, P., Chan, K. C., Musser, B. J., Bar, K. J., Barnabas, R. V., Barouch, D. H., Cohen, M. S., Hurt, C. B., Burwen, D. R., Marovich, M. A., Brown, E. R., Heirman, I., Davis, J. D., Turner, K. C., Ramesh, D., Mahmood, A., Hooper, A. T., Hamilton, J. D., Kim, Y., Purcell, L. A., Baum, A., Kyratsous, C. A., Krainson, J., Perez-Perez, R., Mohseni, R., Kowal, B., DiCioccio, A. T., Geba, G. P., Stahl, N., Lipsich, L., Braunstein, N., Herman, G., Yancopoulos, G. D., Weinreich, D. M. 2022

  Abstract

  Easy-to-administer anti-SARS-CoV-2 treatments may be used to prevent progression from asymptomatic infection to symptomatic disease and to reduce viral carriage.To evaluate the effect of combination subcutaneous casirivimab and imdevimab on progression from early asymptomatic SARS-CoV-2 infection to symptomatic COVID-19.Randomized, double-blind, placebo-controlled, phase 3 trial of close household contacts of a SARS-CoV-2-infected index case at 112 sites in the US, Romania, and Moldova enrolled July 13, 2020-January 28, 2021; follow-up ended March 11, 2021. Asymptomatic individuals (aged ≥12 years) were eligible if identified within 96 hours of index case positive test collection. Results from 314 individuals positive on SARS-CoV-2 reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) testing are reported.Individuals were randomized 1:1 to receive 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each; n = 158), or placebo (n = 156).The primary end point was the proportion of seronegative participants who developed symptomatic COVID-19 during the 28-day efficacy assessment period. The key secondary efficacy end points were the number of weeks of symptomatic SARS-CoV-2 infection and the number of weeks of high viral load (>4 log10 copies/mL).Among 314 randomized participants (mean age, 41.0 years; 51.6% women), 310 (99.7%) completed the efficacy assessment period; 204 were asymptomatic and seronegative at baseline and included in the primary efficacy analysis. Subcutaneous casirivimab and imdevimab, 1200 mg, significantly prevented progression to symptomatic disease (29/100 [29.0%] vs 44/104 [42.3%] with placebo; odds ratio, 0.54 [95% CI, 0.30-0.97]; P = .04; absolute risk difference, -13.3% [95% CI, -26.3% to -0.3%]). Casirivimab and imdevimab reduced the number of symptomatic weeks per 1000 participants (895.7 weeks vs 1637.4 weeks with placebo; P = .03), an approximately 5.6-day reduction in symptom duration per symptomatic participant. Treatment with casirivimab and imdevimab also reduced the number of high viral load weeks per 1000 participants (489.8 weeks vs 811.9 weeks with placebo; P = .001). The proportion of participants receiving casirivimab and imdevimab who had 1 or more treatment-emergent adverse event was 33.5% vs 48.1% for placebo, including events related (25.8% vs 39.7%) or not related (11.0% vs 16.0%) to COVID-19.Among asymptomatic SARS-CoV-2 RT-qPCR-positive individuals living with an infected household contact, treatment with subcutaneous casirivimab and imdevimab antibody combination vs placebo significantly reduced the incidence of symptomatic COVID-19 over 28 days.ClinicalTrials.gov Identifier: NCT04452318.

  View details for DOI 10.1001/jama.2021.24939

  View details for PubMedID 35029629

• REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. The New England journal of medicine Weinreich, D. M., Sivapalasingam, S., Norton, T., Ali, S., Gao, H., Bhore, R., Xiao, J., Hooper, A. T., Hamilton, J. D., Musser, B. J., Rofail, D., Hussein, M., Im, J., Atmodjo, D. Y., Perry, C., Pan, C., Mahmood, A., Hosain, R., Davis, J. D., Turner, K. C., Baum, A., Kyratsous, C. A., Kim, Y., Cook, A., Kampman, W., Roque-Guerrero, L., Acloque, G., Aazami, H., Cannon, K., Simón-Campos, J. A., Bocchini, J. A., Kowal, B., DiCioccio, A. T., Soo, Y., Geba, G. P., Stahl, N., Lipsich, L., Braunstein, N., Herman, G., Yancopoulos, G. D. 2021; 385 (23): e81

  Abstract

  In the phase 1-2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.In the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated.Covid-19-related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P = 0.002). The median time to resolution of symptoms was 4 days shorter with each REGEN-COV dose than with placebo (10 days vs. 14 days; P<0.001 for both comparisons). REGEN-COV was efficacious across various subgroups, including patients who were SARS-CoV-2 serum antibody-positive at baseline. Both REGEN-COV doses reduced viral load faster than placebo; the least-squares mean difference in viral load from baseline through day 7 was -0.71 log10 copies per milliliter (95% confidence interval [CI], -0.90 to -0.53) in the 1200-mg group and -0.86 log10 copies per milliliter (95% CI, -1.00 to -0.72) in the 2400-mg group. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200-mg group (1.1%) and the 2400-mg group (1.3%); infusion-related reactions of grade 2 or higher occurred in less than 0.3% of the patients in all groups.REGEN-COV reduced the risk of Covid-19-related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04425629.).

  View details for DOI 10.1056/NEJMoa2108163

  View details for PubMedID 34587383

  View details for PubMedCentralID PMC8522800

• Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. The New England journal of medicine O'Brien, M. P., Forleo-Neto, E., Musser, B. J., Isa, F., Chan, K. C., Sarkar, N., Bar, K. J., Barnabas, R. V., Barouch, D. H., Cohen, M. S., Hurt, C. B., Burwen, D. R., Marovich, M. A., Hou, P., Heirman, I., Davis, J. D., Turner, K. C., Ramesh, D., Mahmood, A., Hooper, A. T., Hamilton, J. D., Kim, Y., Purcell, L. A., Baum, A., Kyratsous, C. A., Krainson, J., Perez-Perez, R., Mohseni, R., Kowal, B., DiCioccio, A. T., Stahl, N., Lipsich, L., Braunstein, N., Herman, G., Yancopoulos, G. D., Weinreich, D. M. 2021; 385 (13): 1184-1195

  Abstract

  REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among high-risk persons with coronavirus disease 2019 (Covid-19). Whether subcutaneous REGEN-COV prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent Covid-19 in persons at high risk for infection because of household exposure to a person with SARS-CoV-2 infection is unknown.We randomly assigned, in a 1:1 ratio, participants (≥12 years of age) who were enrolled within 96 hours after a household contact received a diagnosis of SARS-CoV-2 infection to receive a total dose of 1200 mg of REGEN-COV or matching placebo administered by means of subcutaneous injection. At the time of randomization, participants were stratified according to the results of the local diagnostic assay for SARS-CoV-2 and according to age. The primary efficacy end point was the development of symptomatic SARS-CoV-2 infection through day 28 in participants who did not have SARS-CoV-2 infection (as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay) or previous immunity (seronegativity).Symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5%) and in 59 of 752 participants in the placebo group (7.8%) (relative risk reduction [1 minus the relative risk], 81.4%; P<0.001). In weeks 2 to 4, a total of 2 of 753 participants in the REGEN-COV group (0.3%) and 27 of 752 participants in the placebo group (3.6%) had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6%). REGEN-COV also prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%). Among symptomatic infected participants, the median time to resolution of symptoms was 2 weeks shorter with REGEN-COV than with placebo (1.2 weeks and 3.2 weeks, respectively), and the duration of a high viral load (>104 copies per milliliter) was shorter (0.4 weeks and 1.3 weeks, respectively). No dose-limiting toxic effects of REGEN-COV were noted.Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04452318.).

  View details for DOI 10.1056/NEJMoa2109682

  View details for PubMedID 34347950

  View details for PubMedCentralID PMC8362593

• Skin and Soft Tissue Infections in Patients with Diabetes Mellitus. Infectious disease clinics of North America Polk, C., Sampson, M. M., Roshdy, D., Davidson, L. E. 2021; 35 (1): 183-197

  Abstract

  Skin and soft tissue infections are common in diabetics. Diabetic foot infection usually results from disruption of the skin barrier, trauma, pressure, or ischemic wounds. These wounds may become secondarily infected or lead to development of adjacent soft tissue or deeper bone infection. Clinical assessment and diagnosis of these conditions using a multidisciplinary management approach, including careful attention to antibiotic selection, lead to the best outcomes in patient care.

  View details for DOI 10.1016/j.idc.2020.10.007

  View details for PubMedID 33303332

• A Plethora of Pustules: Acute Generalized Exanthematous Pustulosis. The American journal of medicine Sampson, M. M., Klinkova, O., Vitko, J., Casanas, B. 2018; 131 (6): 639-641

  View details for DOI 10.1016/j.amjmed.2018.01.018

  View details for PubMedID 29425705

• Reflecting on Resident Attitudes About Quality Improvement. Academic medicine : journal of the Association of American Medical Colleges Sampson, M. M., Cheng, S., Olson, D. A. 2017; 92 (11): 1509

  View details for DOI 10.1097/ACM.0000000000001944

  View details for PubMedID 29064996

• Mucositis and oral infections secondary to gram negative rods in patients with prolonged neutropenia. IDCases Sampson, M. M., Nanjappa, S., Greene, J. N. 2017; 9: 101-103

  Abstract

  Patients with prolonged neutropenia are at risk for a variety of complications and infections including the development of mucositis and oral ulcers. The changes in oral flora during chemotherapy and its effects on the development of infections of the oral cavity have been studied with inconsistent results. However, there is evidence that supports the colonization of gram negative rods in patients undergoing chemotherapy. In this report, we present two leukemic patients who developed oral ulcers secondary to multi-drug resistant Pseudomonas aeruginosa. It is important to suspect multi-drug resistant gram negative rods in patients with prolonged neutropenia who develop gum infections despite appropriate antibiotic coverage.

  View details for DOI 10.1016/j.idcr.2017.06.014

  View details for PubMedID 28736716

  View details for PubMedCentralID PMC5512178

• Prevalence of gastrointestinal parasites in children from Verón, a rural city of the Dominican Republic. Research and reports in tropical medicine Childers, K. A., Palmieri, J. R., Sampson, M., Brunet, D. 2014; 5: 45-53

  Abstract

  Gastrointestinal infections impose a great and often silent burden of morbidity and mortality on poor populations in developing countries. The Dominican Republic (DR) is a nation on the island of Hispaniola in the Caribbean Sea. Verón is located in La Alta Grácia province in the southeastern corner of the DR. Dominican and Haitian migrant workers come to Verón to work in Punta Cana, a tourist resort area. Few definitive or comprehensive studies of the prevalence of gastrointestinal parasitic infections have been published in the DR. Historically, most of the definitive studies of water-borne or soil-transmitted parasites in the DR were published more than 30 years ago. Presently, there is a high prevalence of gastrointestinal parasitic infections throughout the poorest areas of the DR and Haiti. In this study we report the prevalence of gastrointestinal protozoan and helminth parasites from children recruited from the Clínica Rural de Verón during 2008 through 2011. Each participant was asked to provide a fecal sample which was promptly examined microscopically for protozoan and helminth parasites using the Centers for Disease Control and Prevention (CDC) fecal flotation technique to concentrate and isolate helminth ova and protozoan cysts. Of the 128 fecal samples examined, 127 were positive for one or more parasites. The age of the infected children ranged from 2-15 years; 61 were males and 66 were females. The only uninfected child was a 9 year old female. Percent infection rates were 43.8% for Ascaris lumbricoides, 8.5% for Enterobius vermicularis, 21.1% for Entamoeba histolytica, and 22.7% for Giardia duodenalis. Of the children examined, 7.8% had double infections. Any plan of action to reduce gastrointestinal parasites in children will require a determined effort between international, national, and local health authorities combined with improved education of schools, child care providers, food handlers, and agricultural workers. A special effort must be made to reach out to both documented and undocumented immigrants working or living in the area and to pre-school aged children or those who are not part of the public education system. Lastly, it is important to address the microbial water quality and food preparation, especially during the weaning transition to solid foods and throughout childhood.

  View details for DOI 10.2147/RRTM.S64948

  View details for PubMedID 32669891

  View details for PubMedCentralID PMC7337153