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2. Clinical Impact of Ceftriaxone Resistance in Escherichia coli Bloodstream Infections: A Multicenter Prospective Cohort Study

Author

Tamma, Pranita D, Komarow, Lauren, Ge, Lizhao, Garcia-Diaz, Julia, Herc, Erica S, Doi, Yohei, Arias, Cesar A, Albin, Owen, Saade, Elie, Miller, Loren G, Jacob, Jesse T, Satlin, Michael J, Krsak, Martin, Huskins, W Charles, Dhar, Sorabh, Shelburne, Samuel A, Hill, Carol, Baum, Keri R, Bhojani, Minal, Greenwood-Quaintance, Kerryl E, Schmidt-Malan, Suzannah M, Patel, Robin, Evans, Scott R, Chambers, Henry F, Fowler, Vance G, van Duin, David, and Group, for the Antibacterial Resistance Leadership

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Hematology, Sepsis, Infection, bacteremia, ceftriaxone, Escherichia coli, ESBL, mortality, resistance, Antibacterial Resistance Leadership Group, Clinical sciences, Medical microbiology
Abstract

BackgroundCeftriaxone-resistant (CRO-R) Escherichia coli bloodstream infections (BSIs) are common.MethodsThis is a prospective cohort of patients with E coli BSI at 14 United States hospitals between November 2020 and April 2021. For each patient with a CRO-R E coli BSI enrolled, the next consecutive patient with a ceftriaxone-susceptible (CRO-S) E coli BSI was included. Primary outcome was desirability of outcome ranking (DOOR) at day 30, with 50% probability of worse outcomes in the CRO-R group as the null hypothesis. Inverse probability weighting (IPW) was used to reduce confounding.ResultsNotable differences between patients infected with CRO-R and CRO-S E coli BSI included the proportion with Pitt bacteremia score ≥4 (23% vs 15%, P = .079) and the median time to active antibiotic therapy (12 hours [interquartile range {IQR}, 1-35 hours] vs 1 hour [IQR, 0-6 hours]; P < .001). Unadjusted DOOR analyses indicated a 58% probability (95% confidence interval [CI], 52%-63%) for a worse clinical outcome in CRO-R versus CRO-S BSI. In the IPW-adjusted cohort, no difference was observed (54% [95% CI, 47%-61%]). Secondary outcomes included unadjusted and adjusted differences in the proportion of 30-day mortality between CRO-R and CRO-S BSIs (-5.3% [95% CI, -10.3% to -.4%] and -1.8 [95% CI, -6.7% to 3.2%], respectively), postculture median length of stay (8 days [IQR, 5-13 days] vs 6 days [IQR, 4-9 days]; P < .001), and incident admission to a long-term care facility (22% vs 12%, P = .045).ConclusionsPatients with CRO-R E coli BSI generally have poorer outcomes compared to patients infected with CRO-S E coli BSI, even after adjusting for important confounders.

Published
2022

3. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

Author

Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Marόn-Alfaro, Gabriella M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth E, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, and Nakamura, Mari M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Pediatric Research Initiative, Infectious Diseases, Hematology, Biotechnology, Health Services, Patient Safety, Clinical Research, Pediatric, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antiviral Agents, COVID-19, Child, Drug Approval, Female, Humans, Male, Pandemics, Pneumonia, Viral, SARS-CoV-2, United States, United States Food and Drug Administration, COVID-19 Drug Treatment, bamlanivimab, casirivimab, imdevimab, pediatric, Medical microbiology, Paediatrics
Abstract

BackgroundIn November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.ConclusionsBased on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

Published
2021

4. Association Between the First-Hour Intravenous Fluid Volume and Mortality in Pediatric Septic Shock

Author

Auletta, Jeffery J., Barchi, Katie, Braun, Benjamin R., Brilli, Richard J., Campbell, Deborah R., Chinnock, Richard E., Corboy, Jacqueline B., Depinet, Holly E., Dykstra-Nykanen, Jill, Genzel, Karen A., Hakim, Hana, Hron, Jonathan D., Hueschen, Leslie A., Huskins, W. Charles, Kandil, Sarah B., Kawai, Yu, Laurich, V. Matt, Loberger, Jeremy M., Macias, Charles G., Mackenzie, Joan E., Mack, Elizabeth H., Nagpal, Ashish S., Niedner, Matthew, Park, Daniel B., Razzaqi, Faisal, Redfern, Wendi S., Rosen, Johanna R., Rozenfeld, Ranna A., Selby, Sam, Sharron, Matthew P., Silverman, Jonathan A., Spack, Lawrence D., Stalets, Erika L., Thukaram, Roopa, Wathen, Beth A., Wilkes, Jennifer J., Workman, Jennifer K., Zuccaro, Jennifer C., Eisenberg, Matthew A., Riggs, Ruth, Paul, Raina, Balamuth, Fran, Richardson, Troy, DeSouza, Heidi G., Abbadesa, Mary Kate, DeMartini, Theodore K.M., Frizzola, Meg, Lane, Roni, Lloyd, Julia, Melendez, Elliot, Patankar, Nikhil, Rutman, Lori, Sebring, Amanda, Timmons, Zebulon, and Scott, Halden F.

Published
2022
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5. Clinical outcomes in patients infected with ertapenem-only-resistant Enterobacterales versus multi-carbapenem-resistant Enterobacterales

Author

Weston, Gregory, primary, Giri, Abhigya, additional, Komarow, Lauren, additional, Ge, Lizhao, additional, Baum, Keri R, additional, Abbenante, Erin, additional, Gallagher, Jason C, additional, Jacob, Jesse T, additional, Kaye, Keith S, additional, Kim, Angela C, additional, Huskins, W Charles, additional, Zervos, Marcus, additional, Herc, Erica, additional, Patel, Robin, additional, Van Duin, David, additional, and Doi, Yohei, additional

Published
2024
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6. Delays to Antibiotics in the Emergency Department and Risk of Mortality in Children With Sepsis

Author

Lane, Roni D., primary, Richardson, Troy, additional, Scott, Halden F., additional, Paul, Raina M., additional, Balamuth, Fran, additional, Eisenberg, Matthew A., additional, Riggs, Ruth, additional, Huskins, W. Charles, additional, Horvat, Christopher M., additional, Keeney, Grant E., additional, Hueschen, Leslie A., additional, Lockwood, Justin M., additional, Gunnala, Vishal, additional, McKee, Bryan P., additional, Patankar, Nikhil, additional, Pinto, Venessa Lynn, additional, Sebring, Amanda M., additional, Sharron, Matthew P., additional, Treseler, Jennifer, additional, Wilkes, Jennifer J., additional, and Workman, Jennifer K., additional

Published
2024
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7. A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model

Author

Razonable, Raymund R., Aloia, Nicole C.E., Anderson, Ryan J., Anil, Gokhan, Arndt, Lori L., Arndt, Richard F., Ausman, Sara E., Bell, Sarah J., Bierle, Dennis M., Billings, Marcie L., Bishop, Rachel K., Cramer, Carl H., Culbertson, Tracy L., Dababneh, Ala S., Derr, Amber N., Epps, Kevin, Flaker, Susan M., Ganesh, Ravindra, Gilmer, Mary A., Urena, Eric Gomez, Gulden, Christopher R., Haack, Tamara L., Hanson, Sara N., Herzog, Jenna R., Heyliger, Alexander, Hokanson, Lex D., Hopkins, Laura H., Horecki, Richard J., Krishna, Bipinchandra Hirisave, Huskins, W. Charles, Jackson, Tammy A., Johnson, Ryan R., Jorgenson, Betty, Kudrna, Cory, Kennedy, Brian D., Klingsporn, Mary K., Kottke, Brian, Larsen, Jennifer J., Lessard, Sarah R., Lutwick, Larry I., Malone, Edward J., III, Matoush, Jennifer A., Micallef, Ivana N., Moehnke, Darcie E., Mohamed, Muhanad, Ness, Colleena N., Olson, Shelly M., Orenstein, Robert, Palraj, Raj, Patel, Janki, Paulson, Damian J., Phelan, David, Peinovich, Margaret T., Ramsey, Wilford L., Rau-Kane, Taunya J., Reid, Kevin I., Reinschmidt, Karen J., Seville, Maria Teresa, Skold, Erin C., Smith, Jill M., Speicher, Leigh L., Spielman, Laurie A., Springer, Donna J., Sweeten, Perry W., Tempelis, Jennifer M., Tulledge-Scheitel, Sidna, Vergidis, Paschalis, Whipple, Daniel C., Wilker, Caroline G., and Destro Borgen, Molly J.

Published
2021
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8. Guidance for prevention and management of COVID-19 in children and adolescents: A consensus statement from the Pediatric Infectious Diseases Society Pediatric COVID-19 Therapies Taskforce

Author

Willis, Zachary I, primary, Oliveira, Carlos R, additional, Abzug, Mark J, additional, Anosike, Brenda I, additional, Ardura, Monica I, additional, Bio, Laura L, additional, Boguniewicz, Juri, additional, Chiotos, Kathleen, additional, Downes, Kevin, additional, Grapentine, Steven P, additional, Hersh, Adam L, additional, Heston, Sarah M, additional, Hijano, Diego R, additional, Huskins, W Charles, additional, James, Scott H, additional, Jones, Sarah, additional, Lockowitz, Christine R, additional, Lloyd, Elizabeth C, additional, MacBrayne, Christine, additional, Maron, Gabriela M, additional, Hayes McDonough, Molly, additional, Miller, Christine M, additional, Morton, Theodore H, additional, Olivero, Rosemary M, additional, Orscheln, Rachel C, additional, Schwenk, Hayden T, additional, Singh, Prachi, additional, Soma, Vijaya L, additional, Sue, Paul K, additional, Vora, Surabhi B, additional, Nakamura, Mari M, additional, and Wolf, Joshua, additional

Published
2024
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9. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)

Author

Evans, Scott R, Rubin, Daniel, Follmann, Dean, Pennello, Gene, Huskins, W Charles, Powers, John H, Schoenfeld, David, Chuang-Stein, Christy, Cosgrove, Sara E, Fowler, Vance G, Lautenbach, Ebbing, and Chambers, Henry F

Subjects
Patient Safety, Clinical Trials and Supportive Activities, Clinical Research, Anti-Bacterial Agents, Bacterial Infections, Clinical Trials as Topic, Drug Resistance, Bacterial, Humans, Research Design, Risk, Treatment Outcome, DOOR, RADAR, antibiotic use strategies, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Clinical trials that compare strategies to optimize antibiotic use are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. The Antibacterial Resistance Leadership Group strives to overcome these challenges through innovative trial design. Response adjusted for duration of antibiotic risk (RADAR) is a novel methodology utilizing a superiority design and a 2-step process: (1) categorizing patients into an overall clinical outcome (based on benefits and harms), and (2) ranking patients with respect to a desirability of outcome ranking (DOOR). DOORs are constructed by assigning higher ranks to patients with (1) better overall clinical outcomes and (2) shorter durations of antibiotic use for similar overall clinical outcomes. DOOR distributions are compared between antibiotic use strategies. The probability that a randomly selected patient will have a better DOOR if assigned to the new strategy is estimated. DOOR/RADAR represents a new paradigm in assessing the risks and benefits of new strategies to optimize antibiotic use.

Published
2015

11. 215. Shorter vs. Longer Duration of Treatment in Patients with Ceftriaxone-resistant and Ceftriaxone-susceptible Escherichia coli Bloodstream Infections

Author

Mackow, Natalie A, primary, Ge, Lizhao, additional, Komarow, Lauren, additional, Shao, Wanying, additional, Herc, Erica, additional, Doi, Yohei, additional, Arias, Cesar A, additional, Albin, Owen, additional, Saade, Elie, additional, Miller, Loren G, additional, Jacob, Jesse T, additional, Satlin, Michael J, additional, Krsak, Martin, additional, Huskins, W Charles, additional, Dhar, Sorabh, additional, Shelburne, Samuel A, additional, Hill, Carol, additional, Greenwood-Quaintance, Kerryl E, additional, Schmidt-Malan, Suzannah, additional, Patel, Robin, additional, Fowler, Vance G, additional, Tamma, Pranita, additional, and van Duin, David, additional

Published
2023
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12. 1708. Molecular Epidemiology of Staphylococcus aureus Isolates Colonizing Infants in a Neonatal Intensive Care Unit: A 4-Year Cohort Study

Author

Reis, Christopher, primary, Siple, Leah M, additional, Stetson, Raymond, additional, Collura, Christopher A, additional, Fang, Jennifer, additional, Gallup, Maria C, additional, Omdahl, Tami, additional, Daniels, Matthew, additional, Starkey, Jordan, additional, Barth, Jean, additional, Sampathkumar, Priya, additional, Chen, Jun, additional, Patel, Robin, additional, and Huskins, W Charles, additional

Published
2023
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16. A 7-Year-Old Boy with Fever and Dark Urine

Author

Chuang, Tony M., primary, Bu, Lihong, additional, Opp, Derek N., additional, Potretzke, Theodora A., additional, Huskins, W. Charles, additional, Van Dorn, Charlotte S., additional, Tran, Cheryl L., additional, Dearani, Joseph A., additional, and Hanna, Christian, additional

Published
2023
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17. Legislative Mandates for Use of Active Surveillance Cultures to Screen for Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococci: Position Statement From the Joint SHEA and APIC Task Force

Author

Weber, Stephen G, Huang, Susan S, Oriola, Shannon, Huskins, W Charles, Noskin, Gary A, Harriman, Kathleen, Olmsted, Russell N, Bonten, Marc, Lundstrom, Tammy, Climo, Michael W, Roghmann, Mary-Claire, Murphy, Cathryn L, and Karchmer, Tobi B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biodefense, Infectious Diseases, Antimicrobial Resistance, Prevention, Emerging Infectious Diseases, Infection, Good Health and Well Being, Advisory Committees, Anti-Bacterial Agents, Culture Media, Enterococcus, Gram-Positive Bacterial Infections, Humans, Infection Control, Methicillin Resistance, Population Surveillance, Societies, Medical, Societies, Scientific, Staphylococcal Infections, Staphylococcus aureus, Vancomycin Resistance, Society for Healthcare Epidemiology of America, Association of Professionals in Infection Control and Epidemiology, bacterium culture, bacterium isolate, cost effectiveness analysis, cross infection, enterococcal infection, health care organization, human, infection control, infection prevention, law, methicillin resistant Staphylococcus aureus, review, risk assessment, screening test, Staphylococcus infection, United States, vancomycin resistant Enterococcus, Medical and Health Sciences, Epidemiology, Biomedical and clinical sciences, Health sciences
Abstract

Legislation aimed at controlling antimicrobial-resistant pathogens through the use of active surveillance cultures to screen hospitalized patients has been introduced in at least 2 US states. In response to the proposed legislation, the Society for Healthcare Epidemiology of America (SHEA) and the Association of Professionals in Infection Control and Epidemiology (APIC) have developed this joint position statement. Both organizations are dedicated to combating healthcare-associated infections with a wide array of methods, including the use of active surveillance cultures in appropriate circumstances. This position statement reviews the proposed legislation and the rationale for use of active surveillance cultures, examines the scientific evidence supporting the use of this strategy, and discusses a number of unresolved issues surrounding legislation mandating use of active surveillance cultures. The following 5 consensus points are offered. (1) Although reducing the burden of antimicrobial-resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE), is of preeminent importance, APIC and SHEA do not support legislation to mandate use of active surveillance cultures to screen for MRSA, VRE, or other antimicrobial-resistant pathogens. (2) SHEA and APIC support the continued development, validation, and application of efficacious and cost-effective strategies for the prevention of infections caused by MRSA, VRE, and other antimicrobial-resistant and antimicrobial-susceptible pathogens. (3) APIC and SHEA welcome efforts by healthcare consumers, together with private, local, state, and federal policy makers, to focus attention on and formulate solutions for the growing problem of antimicrobial resistance and healthcare-associated infections. (4) SHEA and APIC support ongoing additional research to determine and optimize the appropriateness, utility, feasibility, and cost-effectiveness of using active surveillance cultures to screen both lower-risk and high-risk populations. (5) APIC and SHEA support stronger collaboration between state and local public health authorities and institutional infection prevention and control experts.

Published
2007

19. Prioritising respiratory syncytial virus prevention in low-income and middle-income countries

Author

Carbonell-Estrany, Xavier, primary, Simões, Eric AF, additional, Bont, Louis J, additional, Paes, Bosco A, additional, Carbonell-Estrany, Xavier, additional, Ayuk, Adaeze, additional, Gentile, Angela, additional, Greenough, Anne, additional, Moreno, Antonio, additional, Sharma, Arun, additional, Mejias, Asuncion, additional, Rodgers-Gray, Barry, additional, Resch, Bernhard, additional, Fauroux, Brigette, additional, Rodriguez-Martinez, Carlos E, additional, El Saleeby, Chadi, additional, Huskins, W Charles, additional, Cohen, Cheryl, additional, Greenberg, David, additional, Baraldi, Eugenio, additional, Anderson, Evan, additional, Martinon Torres, Federico, additional, Polack, Fernando F, additional, Piedimonte, Giovanni, additional, Nair, Harish, additional, Gans, Hayley, additional, Zar, Heather J, additional, Moriuchi, Hiroyuki, additional, Oshitani, Hitoshi, additional, Mitchell, Ian, additional, Nokes, D James, additional, Sheikh, Jarju, additional, Pernica, Jeffrey, additional, Papenburg, Jesse, additional, Robinson, Joan, additional, De Jesus-Cornejo, Joanne, additional, Langley, Joanne, additional, Liese, Johannes, additional, Figueras Aloy, Jose, additional, Torres Torretti, Juan Pablo, additional, Edwards, Kathryn, additional, Krilov, Leonard, additional, Divaratne, Maduja, additional, Sanchez Luna, Manuel, additional, Lanari, Marcello, additional, Scotta, Marcelo, additional, Garba, Maria, additional, Mori, Masaaki, additional, Cetinkaya, Merih, additional, Goldstein, Mitchell, additional, Khuri-Bulos, Najwa, additional, Vain, Nestor E, additional, Papadopoulus, Nikolaos, additional, Homaira, Nusrat, additional, Ramilo, Octavio, additional, Manzoni, Paolo, additional, Munywoki, Patrick, additional, Piedra, Pedro A, additional, Moschovis, Peter, additional, Openshaw, Peter, additional, Bassat, Quique, additional, Stein, Renato, additional, Thwaites, Richard, additional, Muthugala, Rohitha, additional, Ulloa-Gutierrez, Rolando, additional, Dagan, Ron, additional, Rodriguez Fernandez, Rosa, additional, Kusuda, Satoshi, additional, Madhi, Shabir, additional, Broor, Shobha, additional, Drysdale, Simon B, additional, Basnet, Sudha, additional, Heikkinen, Terho, additional, Avadhanula, Vasanthi, additional, Saez-Llorens, Xavier, additional, Wang, Xin, additional, Li, You, additional, and Mathew, Joseph L, additional

Published
2023
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24. Association Between the First-Hour Intravenous Fluid Volume and Mortality in Pediatric Septic Shock

Author

Eisenberg, Matthew A., primary, Riggs, Ruth, additional, Paul, Raina, additional, Balamuth, Fran, additional, Richardson, Troy, additional, DeSouza, Heidi G., additional, Abbadesa, Mary Kate, additional, DeMartini, Theodore K.M., additional, Frizzola, Meg, additional, Lane, Roni, additional, Lloyd, Julia, additional, Melendez, Elliot, additional, Patankar, Nikhil, additional, Rutman, Lori, additional, Sebring, Amanda, additional, Timmons, Zebulon, additional, Scott, Halden F., additional, Auletta, Jeffery J., additional, Barchi, Katie, additional, Braun, Benjamin R., additional, Brilli, Richard J., additional, Campbell, Deborah R., additional, Chinnock, Richard E., additional, Corboy, Jacqueline B., additional, Depinet, Holly E., additional, Dykstra-Nykanen, Jill, additional, Genzel, Karen A., additional, Hakim, Hana, additional, Hron, Jonathan D., additional, Hueschen, Leslie A., additional, Huskins, W. Charles, additional, Kandil, Sarah B., additional, Kawai, Yu, additional, Laurich, V. Matt, additional, Loberger, Jeremy M., additional, Macias, Charles G., additional, Mackenzie, Joan E., additional, Mack, Elizabeth H., additional, Nagpal, Ashish S., additional, Niedner, Matthew, additional, Park, Daniel B., additional, Razzaqi, Faisal, additional, Redfern, Wendi S., additional, Rosen, Johanna R., additional, Rozenfeld, Ranna A., additional, Selby, Sam, additional, Sharron, Matthew P., additional, Silverman, Jonathan A., additional, Spack, Lawrence D., additional, Stalets, Erika L., additional, Thukaram, Roopa, additional, Wathen, Beth A., additional, Wilkes, Jennifer J., additional, Workman, Jennifer K., additional, and Zuccaro, Jennifer C., additional

Published
2022
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36. Gastrointestinal Microbiome Disruption and Antibiotic-Associated Diarrhea in Children Receiving Antibiotic Therapy for Community-Acquired Pneumonia

Author

Kwon, Jiye, primary, Kong, Yong, additional, Wade, Martina, additional, Williams, Derek J, additional, Creech, Clarence Buddy, additional, Evans, Scott, additional, Walter, Emmanuel B, additional, Martin, Judy M, additional, Gerber, Jeffrey S, additional, Newland, Jason G, additional, Hofto, Meghan E, additional, Staat, Mary Allen, additional, Chambers, Henry F, additional, Fowler, Vance G, additional, Huskins, W Charles, additional, and Pettigrew, Melinda M, additional

Published
2022
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42. A Framework for Outpatient Infusion of Anti-Spike Monoclonal Antibodies to High-Risk Patients with Mild to Moderate Coronavirus Disease-19: The Mayo Clinic Model

Author

Razonable, Raymund R., Aloia, Nicole C.E., Anderson, Ryan J., Anil, Gokhan, Arndt, Lori L., Arndt, Richard F., Ausman, Sara E., Bell, Sarah J., Bierle, Dennis M., Billings, Marcie L., Bishop, Rachel K., Cramer, Carl H., Culbertson, Tracy L., Dababneh, Ala S., Derr, Amber N., Epps, Kevin, Flaker, Susan M., Ganesh, Ravindra, Gilmer, Mary A., Urena, Eric Gomez, Gulden, Christopher R., Haack, Tamara L., Hanson, Sara N., Herzog, Jenna R., Heyliger, Alexander, Hokanson, Lex D., Hopkins, Laura H., Horecki, Richard J., Krishna, Bipinchandra Hirisave, Huskins, W. Charles, Jackson, Tammy A., Johnson, Ryan R., Jorgenson, Betty, Kudrna, Cory, Kennedy, Brian D., Klingsporn, Mary K., Kottke, Brian, Larsen, Jennifer J., Lessard, Sarah R., Lutwick, Larry I., Malone, Edward J., Matoush, Jennifer A., Micallef, Ivana N., Moehnke, Darcie E., Mohamed, Muhanad, Ness, Colleena N., Olson, Shelly M., Orenstein, Robert, Palraj, Raj, Patel, Janki, Paulson, Damian J., Phelan, David, Peinovich, Margaret T., Ramsey, Wilford L., Rau-Kane, Taunya J., Reid, Kevin I., Reinschmidt, Karen J., Seville, Maria Teresa, Skold, Erin C., Smith, Jill M., Speicher, Leigh L., Spielman, Laurie A., Springer, Donna J., Sweeten, Perry W., Tempelis, Jennifer M., Tulledge-Scheitel, Sidna, Vergidis, Paschalis, Whipple, Daniel C., Wilker, Caroline G., and Destro Borgen, Molly J.

Subjects
SARS-CoV-2, Severe Acute Respiratory Syndrome coronavirus-2, COVID-19, coronavirus disease-19, IDSA, Infectious Diseases Society of America, HICS, Healthcare Incident Command, ITC, Infusion Therapy Center, HER, Electronic Health Records, FDA, Food and Drug Administration, Article, NIH, National Institutes of Health, EUA, emergency use authorization, CFCT, COVID-19 Frontline Care Team, IPAC, Infection Prevention and Control, MATRx, Monoclonal Antibody Treatment Team, PCCT, Pediatric COVID-19 Care Team
Abstract

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients, while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, EHR informatics, compliance, legal, medical ethics, engineering, administration and other critical areas. Clear communication and a culture where all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our COVID-19 patients in the outpatient setting are met.

Published
2021

43. Decreasing PICU catheter-associated bloodstream infections: NACHRI's quality transformation efforts

Author

Miller, Marlene R., Griswold, Michael, Harris, J. Mitchell, II, Yenokyan, Gayane, Huskins, W. Charles, Moss, Michele, Rice, Tom B., Ridling, Debra, Campbell, Deborah, Margolis, Peter, Muething, Stephen, and Brilli, Richard J.

Subjects
National Association of Children's Hospitals and Related Institutions -- Quality management, Blood-borne diseases -- Prevention, Blood-borne diseases -- Research, Cross infection -- Prevention, Cross infection -- Research, Nosocomial infections -- Prevention, Nosocomial infections -- Research, Pediatric intensive care units -- Quality management, Pediatric intensive care units -- Research
Published
2010

44. Advancing Clinical Practice through Integration of Congenital Cytomegalovirus (cCMV) Testing with Newborn Hearing Screening at Mayo Clinic

Author

Martin, Joscelyn R. K., Huskins, W. Charles, Schimmenti, Lisa A., Cofer, Shelagh A., and Poling, Gayla L.

Subjects
cCMV, targeted screening, CMV, interprofessional collaborative care, Speech Pathology and Audiology, newborn hearing screening
Abstract

Although cCMV is the leading non-genetic cause of childhood hearing loss in the United States, neither targeted nor universal screening protocols have been well established to identify cCMV in newborns. Moreover, until cCMV testing is universal, clinical protocols need to account for the complexities of individualized care in partnership with interprofessional care teams. This work addressed an immediate clinical practice need to identify cCMV with subsequent hearing monitoring of babies who test positive for cCMV. This effort focused on three primary objectives to: 1) define interprofessional, team-based approach to facilitate care pathways; 2) develop a clinical workflow for all babies who refer on inpatient hearing screening to be tested for cCMV by 21 days of age; 3) develop a hearing monitoring plan for all babies who test positive for cCMV. The development and integration of our interprofessional, team-based approach to institute cCMV testing by 21 days of age on all babies who refer inpatient newborn hearing screening and subsequent monitoring is described. Our observed referral rate was lower than predicted (2.7%) from existing literature with only one positive cCMV outcome noted in the two-year span. This study demonstrates the feasibility of a hearing-targeted cCMV testing paradigm in our clinic practice.

Published
2021
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46. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents.

Author

Wolf, Joshua, Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Maron, Gabriela M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth C, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, Nakamura, Mari M, Wolf, Joshua, Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Maron, Gabriela M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth C, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, and Nakamura, Mari M

Abstract

BackgroundIn November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.ConclusionsBased on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

Published
2021

47. Short- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia in Children

Author

Williams, Derek J., Creech, C. Buddy, Walter, Emmanuel B., Martin, Judith M., Gerber, Jeffrey S., Newland, Jason G., Howard, Lee, Hofto, Meghan E., Staat, Mary A., Oler, Randolph E., Tuyishimire, Bonifride, Conrad, Thomas M., Lee, Marina S., Ghazaryan, Varduhi, Pettigrew, Melinda M, Fowler, Vance G., Chambers, Henry F., Zaoutis, Theoklis E., Evans, Scott, and Huskins, W. Charles

Subjects
Community-Acquired Infections, Male, Double-Blind Method, Child, Preschool, Outpatients, Pediatrics, Perinatology and Child Health, Humans, Female, Pneumonia, Child, Original Investigation, Anti-Bacterial Agents
Abstract

IMPORTANCE: Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects and decreased potential for antibiotic resistance. OBJECTIVE: To compare a short (5-day) vs standard (10-day) antibiotic treatment strategy for CAP in young children. DESIGN, SETTING, AND PARTICIPANTS: Randomized double-blind placebo-controlled clinical trial in outpatient clinic, urgent care, or emergency settings in 8 US cities. A total of 380 healthy children aged 6 to 71 months with nonsevere CAP demonstrating early clinical improvement were enrolled from December 2, 2016, to December 16, 2019. Data were analyzed from January to September 2020. INTERVENTION: On day 6 of their originally prescribed therapy, participants were randomized 1:1 to receive 5 days of matching placebo or 5 additional days of the same antibiotic. MAIN OUTCOMES AND MEASURES: The primary end point was the end-of-treatment response adjusted for duration of antibiotic risk (RADAR), a composite end point that ranks each child’s clinical response, resolution of symptoms, and antibiotic-associated adverse effects in an ordinal desirability of outcome ranking (DOOR). Within each DOOR rank, participants were further ranked by the number of antibiotic days, assuming that shorter antibiotic durations were more desirable. Using RADAR, the probability of a more desirable outcome was estimated for the short- vs standard-course strategy. In a subset of children, throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. RESULTS: A total of 380 children (189 randomized to short course and 191 randomized to standard course) made up the study population. The mean (SD) age was 35.7 (17.2) months, and 194 participants (51%) were male. Of the included children, 8 were Asian, 99 were Black or African American, 234 were White, 32 were multiracial, and 7 were of unknown or unreported race; 33 were Hispanic or Latino, 344 were not Hispanic or Latino, and 3 were of unknown or unreported ethnicity. There were no differences between strategies in the DOOR or its individual components. Fewer than 10% of children in either strategy had an inadequate clinical response. The short-course strategy had a 69% (95% CI, 63-75) probability of a more desirable RADAR outcome compared with the standard-course strategy. A total of 171 children were included in the resistome analysis. The median (range) number of antibiotic resistance genes per prokaryotic cell (RGPC) was significantly lower in the short-course strategy compared with the standard-course strategy for total RGPC (1.17 [0.35-2.43] vs 1.33 [0.46-11.08]; P = .01) and β-lactamase RGPC (0.55 [0.18-1.24] vs 0.60 [0.21-2.45]; P = .03). CONCLUSIONS AND RELEVANCE: In this study, among children responding to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior to a 10-day strategy. The shortened approach resulted in similar clinical response and antibiotic-associated adverse effects, while reducing antibiotic exposure and resistance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02891915.

Published
2022
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48. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship

Author

Dellit, Timothy H., Owens, Robert C., McGowan, John E., Jr., Gerding, Dale N., Weinstein, Robert A., Burke, John P., Huskins, W. Charles, Paterson, David L., Fishman, Neil O., Carpenter, Christopher F., Brennan, P.J., Billeter, Marianne, and Hooton, Thomas M.

Subjects
Anti-infective agents -- Dosage and administration, Anti-infective agents -- Standards, Medical societies -- Standards, Health, Health care industry, Infectious Diseases Society of America -- Standards
Published
2007

49. Legislative mandates for use of active surveillance cultures to screen for methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci: Position statement from the Joint SHEA and APIC Task Force

Author

Weber, Stephen G., Huang, Susan S., Oriola, Shannon, Huskins, W. Charles, Noskin, Gary A., Harriman, Kathleen, Olmsted, Russell N., Bonten, Marc, Lundstrom, Tammy, Climo, Michael W., Roghmann, Mary-Claire, Murphy, Cathryn L., and Karchmer, Tobi B.

Published
2007
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50. Hand hygiene and the sequence of patient care

Author

Chang, Nai-Chung, primary, Jones, Michael, additional, Reisinger, Heather Schacht, additional, Schweizer, Marin L., additional, Chrischilles, Elizabeth, additional, Chorazy, Margaret, additional, Huskins, W. Charles, additional, and Herwaldt, Loreen, additional

Published
2021
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