Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
NCT ID: NCT05975671
Last Updated: 2025-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
52500 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-21
Study Completion Date
2026-05-31
Brief Summary
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The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU).
There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:
* Implementation of a clinical guideline indicating when vancomycin should and should not be used
* Unit-level feedback on overall vancomycin use within and across centers
* Clinician education.
There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:
* Implementation of a clinical guideline indicating when vancomycin should and should not be used
* Unit-level feedback on overall vancomycin use within and across centers
* Clinician education.
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Detailed Description
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Vancomycin is among the most commonly prescribed antibiotics in United States children's hospitals, and inappropriate use of vancomycin is common. Given the high prevalence of acute kidney injury associated with vancomycin of up to 25%, reducing vancomycin overuse is a key opportunity to reduce preventable patient harm.
The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention.
During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy \[DOT\]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis.
During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including:
* The creation of a consensus guideline for vancomycin use;
* Ad hoc education related to vancomycin overuse, and;
* Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites).
This intervention will be locally adapted by the investigative team and sepsis stakeholders at each site. Data from the EHR will be used to assess vancomycin use (DOT/1000 patient days), as well as the secondary outcomes. Investigators will perform semi-structured interviews and repeat surveys 9 months after the implementation of the intervention. This mixed-methods process and formative evaluation will help investigators understand which elements of implementation were successful and which were not.
The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention.
During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy \[DOT\]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis.
During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including:
* The creation of a consensus guideline for vancomycin use;
* Ad hoc education related to vancomycin overuse, and;
* Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites).
This intervention will be locally adapted by the investigative team and sepsis stakeholders at each site. Data from the EHR will be used to assess vancomycin use (DOT/1000 patient days), as well as the secondary outcomes. Investigators will perform semi-structured interviews and repeat surveys 9 months after the implementation of the intervention. This mixed-methods process and formative evaluation will help investigators understand which elements of implementation were successful and which were not.
Conditions
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Sepsis
Sepsis Mrsa
Sepsis Bacteremia
Antimicrobial - Induced Nephropathy
Sepsis, Severe
Septic Shock
Septic Syndrome
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Multicenter, mixed methods, implementation science study with a quasi-experimental design.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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PICU Clinicians and Sepsis stakeholders
Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention:
* All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention.
* Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders.
* Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.
Group Type
OTHER
Multifaceted de-implementation strategy to reduce vancomycin overuse
Intervention Type
BEHAVIORAL
* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site.
* The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews.
* The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.
PICU Patients with suspected sepsis
Research procedures involving patients will be limited to medical record review. This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes. Approximately 50,000 patients will participate in the study. Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files. These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode). The study Identification (ID) number will be used to identify each unique patient. Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Multifaceted de-implementation strategy to reduce vancomycin overuse
* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site.
* The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews.
* The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Mixed methods intervention
Eligibility Criteria
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Inclusion Criteria
* Admitted to one of the participating PICUs during the study period
1. PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
2. Age ≥ 18 years old
3. Employed by one of the participating sites
1. PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
2. Age ≥ 18 years old
3. Employed by one of the participating sites
Exclusion Criteria
* None
1. Volunteers or other non-employee hospital staff
2. Limited English proficiency
1. Volunteers or other non-employee hospital staff
2. Limited English proficiency
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Healthcare of Atlanta
OTHER
Sponsor Role
collaborator
St. Louis Children's Hospital
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
collaborator
Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kathleen Chiotos, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
children's hospital of philadelphia
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Site Status
RECRUITING
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Site Status
RECRUITING
St. Louis Children's Hospital
St Louis, Missouri, United States
Site Status
RECRUITING
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Kissoon N, Reinhart K, Daniels R, Machado MFR, Schachter RD, Finfer S. Sepsis in Children: Global Implications of the World Health Assembly Resolution on Sepsis. Pediatr Crit Care Med. 2017 Dec;18(12):e625-e627. doi: 10.1097/PCC.0000000000001340.
Reference Type
BACKGROUND
Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.
Reference Type
BACKGROUND
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.
Reference Type
BACKGROUND
Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938.
Reference Type
BACKGROUND
Same RG, Hsu AJ, Cosgrove SE, Klein EY, Amoah J, Hersh AL, Kronman MP, Tamma PD. Antibiotic-Associated Adverse Events in Hospitalized Children. J Pediatric Infect Dis Soc. 2021 May 28;10(5):622-628. doi: 10.1093/jpids/piaa173.
Reference Type
BACKGROUND
Hensgens MP, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012 Mar;67(3):742-8. doi: 10.1093/jac/dkr508. Epub 2011 Dec 6.
Reference Type
BACKGROUND
Bell BG, Schellevis F, Stobberingh E, Goossens H, Pringle M. A systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance. BMC Infect Dis. 2014 Jan 9;14:13. doi: 10.1186/1471-2334-14-13.
Reference Type
BACKGROUND
Lovegrove MC, Geller AI, Fleming-Dutra KE, Shehab N, Sapiano MRP, Budnitz DS. US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011-2015. J Pediatric Infect Dis Soc. 2019 Nov 6;8(5):384-391. doi: 10.1093/jpids/piy066.
Reference Type
BACKGROUND
Downes KJ, Cowden C, Laskin BL, Huang YS, Gong W, Bryan M, Fisher BT, Goldstein SL, Zaoutis TE. Association of Acute Kidney Injury With Concomitant Vancomycin and Piperacillin/Tazobactam Treatment Among Hospitalized Children. JAMA Pediatr. 2017 Dec 4;171(12):e173219. doi: 10.1001/jamapediatrics.2017.3219. Epub 2017 Dec 4.
Reference Type
BACKGROUND
Navalkele B, Pogue JM, Karino S, Nishan B, Salim M, Solanki S, Pervaiz A, Tashtoush N, Shaikh H, Koppula S, Koons J, Hussain T, Perry W, Evans R, Martin ET, Mynatt RP, Murray KP, Rybak MJ, Kaye KS. Risk of Acute Kidney Injury in Patients on Concomitant Vancomycin and Piperacillin-Tazobactam Compared to Those on Vancomycin and Cefepime. Clin Infect Dis. 2017 Jan 15;64(2):116-123. doi: 10.1093/cid/ciw709. Epub 2016 Oct 20.
Reference Type
BACKGROUND
Rutter WC, Cox JN, Martin CA, Burgess DR, Burgess DS. Nephrotoxicity during Vancomycin Therapy in Combination with Piperacillin-Tazobactam or Cefepime. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e02089-16. doi: 10.1128/AAC.02089-16. Print 2017 Feb.
Reference Type
BACKGROUND
Dethlefsen L, Huse S, Sogin ML, Relman DA. The pervasive effects of an antibiotic on the human gut microbiota, as revealed by deep 16S rRNA sequencing. PLoS Biol. 2008 Nov 18;6(11):e280. doi: 10.1371/journal.pbio.0060280.
Reference Type
BACKGROUND
McKamy S, Hernandez E, Jahng M, Moriwaki T, Deveikis A, Le J. Incidence and risk factors influencing the development of vancomycin nephrotoxicity in children. J Pediatr. 2011 Mar;158(3):422-6. doi: 10.1016/j.jpeds.2010.08.019.
Reference Type
BACKGROUND
Sinclair EA, Yenokyan G, McMunn A, Fadrowski JJ, Milstone AM, Lee CK. Factors associated with acute kidney injury in children receiving vancomycin. Ann Pharmacother. 2014 Dec;48(12):1555-62. doi: 10.1177/1060028014549185. Epub 2014 Sep 3.
Reference Type
BACKGROUND
Ragab AR, Al-Mazroua MK, Al-Harony MA. Incidence and predisposing factors of vancomycin-induced nephrotoxicity in children. Infect Dis Ther. 2013 Jun;2(1):37-46. doi: 10.1007/s40121-013-0004-8. Epub 2013 Mar 26.
Reference Type
BACKGROUND
Fiorito TM, Luther MK, Dennehy PH, LaPlante KL, Matson KL. Nephrotoxicity With Vancomycin in the Pediatric Population: A Systematic Review and Meta-Analysis. Pediatr Infect Dis J. 2018 Jul;37(7):654-661. doi: 10.1097/INF.0000000000001882.
Reference Type
BACKGROUND
Feiten HDS, Okumura LM, Martinbiancho JK, Andreolio C, da Rocha TS, Antonacci Carvalho PR, Pedro Piva J. Vancomycin-associated Nephrotoxicity and Risk Factors in Critically Ill Children Without Preexisting Renal Injury. Pediatr Infect Dis J. 2019 Sep;38(9):934-938. doi: 10.1097/INF.0000000000002391.
Reference Type
BACKGROUND
Bradley JS, Byington CL, Shah SS, Alverson B, Carter ER, Harrison C, Kaplan SL, Mace SE, McCracken GH Jr, Moore MR, St Peter SD, Stockwell JA, Swanson JT; Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis. 2011 Oct;53(7):e25-76. doi: 10.1093/cid/cir531. Epub 2011 Aug 31.
Reference Type
BACKGROUND
Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
Reference Type
BACKGROUND
Tribble AC, Lee BR, Flett KB, Handy LK, Gerber JS, Hersh AL, Kronman MP, Terrill CM, Sharland M, Newland JG; Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative. Appropriateness of Antibiotic Prescribing in United States Children's Hospitals: A National Point Prevalence Survey. Clin Infect Dis. 2020 Nov 5;71(8):e226-e234. doi: 10.1093/cid/ciaa036.
Reference Type
BACKGROUND
Brogan TV, Thurm C, Hersh AL, Gerber JS, Smith MJ, Shah SS, Courter JD, Patel SJ, Parker SK, Kronman MP, Lee BR, Newland JG. Variability in Antibiotic Use Across PICUs. Pediatr Crit Care Med. 2018 Jun;19(6):519-527. doi: 10.1097/PCC.0000000000001535.
Reference Type
BACKGROUND
Blinova E, Lau E, Bitnun A, Cox P, Schwartz S, Atenafu E, Yau Y, Streitenberger L, Parshuram CS, Marshall J, Seto W. Point prevalence survey of antimicrobial utilization in the cardiac and pediatric critical care unit. Pediatr Crit Care Med. 2013 Jul;14(6):e280-8. doi: 10.1097/PCC.0b013e31828a846d.
Reference Type
BACKGROUND
Williams MC, Obermeier H, Hurst AL, Saporta-Keating SR, Pearce K, MacBrayne CE, Child J, Parker SK. Hospital-wide Description of Clinical Indications for Pediatric Anti-infective Use. Clin Ther. 2019 Aug;41(8):1605-1611.e0. doi: 10.1016/j.clinthera.2019.05.008. Epub 2019 Jun 11.
Reference Type
BACKGROUND
Mermel LA. Respiratory protection for healthcare workers caring for COVID-19 patients. Infect Control Hosp Epidemiol. 2020 Sep;41(9):1064-1065. doi: 10.1017/ice.2020.175. Epub 2020 Apr 23. No abstract available.
Reference Type
BACKGROUND
Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.
Reference Type
BACKGROUND
Levine DP. Vancomycin: a history. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S5-12. doi: 10.1086/491709.
Reference Type
BACKGROUND
Weiner-Lastinger LM, Abner S, Benin AL, Edwards JR, Kallen AJ, Karlsson M, Magill SS, Pollock D, See I, Soe MM, Walters MS, Dudeck MA. Antimicrobial-resistant pathogens associated with pediatric healthcare-associated infections: Summary of data reported to the National Healthcare Safety Network, 2015-2017. Infect Control Hosp Epidemiol. 2020 Jan;41(1):19-30. doi: 10.1017/ice.2019.297. Epub 2019 Nov 25.
Reference Type
BACKGROUND
Waters CD, Caraccio J. Rate of positive cultures necessitating definitive treatment in patients receiving empiric vancomycin therapy. Infect Control Hosp Epidemiol. 2018 Aug;39(8):989-990. doi: 10.1017/ice.2018.123. Epub 2018 Jun 12.
Reference Type
BACKGROUND
Jones M, Jernigan JA, Evans ME, Roselle GA, Hatfield KM, Samore MH. Vital Signs: Trends in Staphylococcus aureus Infections in Veterans Affairs Medical Centers - United States, 2005-2017. MMWR Morb Mortal Wkly Rep. 2019 Mar 8;68(9):220-224. doi: 10.15585/mmwr.mm6809e2.
Reference Type
BACKGROUND
Jones BE, Jones MM, Huttner B, Stoddard G, Brown KA, Stevens VW, Greene T, Sauer B, Madaras-Kelly K, Rubin M, Goetz MB, Samore M. Trends in Antibiotic Use and Nosocomial Pathogens in Hospitalized Veterans With Pneumonia at 128 Medical Centers, 2006-2010. Clin Infect Dis. 2015 Nov 1;61(9):1403-10. doi: 10.1093/cid/civ629. Epub 2015 Jul 29.
Reference Type
BACKGROUND
Jones BE, Brown KA, Jones MM, Huttner BD, Greene T, Sauer BC, Madaras-Kelly K, Rubin MA, Bidwell Goetz M, Samore MH. Variation in Empiric Coverage Versus Detection of Methicillin-Resistant Staphylococcus aureus and Pseudomonas aeruginosa in Hospitalizations for Community-Onset Pneumonia Across 128 US Veterans Affairs Medical Centers. Infect Control Hosp Epidemiol. 2017 Aug;38(8):937-944. doi: 10.1017/ice.2017.98. Epub 2017 Jun 21.
Reference Type
BACKGROUND
Sutter DE, Milburn E, Chukwuma U, Dzialowy N, Maranich AM, Hospenthal DR. Changing Susceptibility of Staphylococcus aureus in a US Pediatric Population. Pediatrics. 2016 Apr;137(4):e20153099. doi: 10.1542/peds.2015-3099. Epub 2016 Mar 1.
Reference Type
BACKGROUND
Kim NH, Koo HL, Choe PG, Cheon S, Kim M, Lee MJ, Jung Y, Park WB, Song KH, Kim ES, Bang JH, Kim HB, Park SW, Kim NJ, Oh MD, Kim EC. Inappropriate continued empirical vancomycin use in a hospital with a high prevalence of methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2015 Feb;59(2):811-7. doi: 10.1128/AAC.04523-14. Epub 2014 Nov 17.
Reference Type
BACKGROUND
Davies P, Evans C, Kanthimathinathan HK, Lillie J, Brierley J, Waters G, Johnson M, Griffiths B, du Pre P, Mohammad Z, Deep A, Playfor S, Singh D, Inwald D, Jardine M, Ross O, Shetty N, Worrall M, Sinha R, Koul A, Whittaker E, Vyas H, Scholefield BR, Ramnarayan P. Intensive care admissions of children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in the UK: a multicentre observational study. Lancet Child Adolesc Health. 2020 Sep;4(9):669-677. doi: 10.1016/S2352-4642(20)30215-7. Epub 2020 Jul 9.
Reference Type
BACKGROUND
Choe PG, Koo HL, Yoon D, Bae JY, Lee E, Hwang JH, Song KH, Park WB, Bang JH, Kim ES, Kim HB, Park SW, Oh MD, Kim NJ. Effect of an intervention targeting inappropriate continued empirical parenteral vancomycin use: a quasi-experimental study in a region of high MRSA prevalence. BMC Infect Dis. 2018 Apr 16;18(1):178. doi: 10.1186/s12879-018-3081-1.
Reference Type
BACKGROUND
Junior MS, Correa L, Marra AR, Camargo LF, Pereira CA. Analysis of vancomycin use and associated risk factors in a university teaching hospital: a prospective cohort study. BMC Infect Dis. 2007 Aug 1;7:88. doi: 10.1186/1471-2334-7-88.
Reference Type
BACKGROUND
Rhee C, Kadri SS, Dekker JP, Danner RL, Chen HC, Fram D, Zhang F, Wang R, Klompas M; CDC Prevention Epicenters Program. Prevalence of Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated With Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA Netw Open. 2020 Apr 1;3(4):e202899. doi: 10.1001/jamanetworkopen.2020.2899.
Reference Type
BACKGROUND
Jones BE, Ying J, Stevens V, Haroldsen C, He T, Nevers M, Christensen MA, Nelson RE, Stoddard GJ, Sauer BC, Yarbrough PM, Jones MM, Goetz MB, Greene T, Samore MH. Empirical Anti-MRSA vs Standard Antibiotic Therapy and Risk of 30-Day Mortality in Patients Hospitalized for Pneumonia. JAMA Intern Med. 2020 Apr 1;180(4):552-560. doi: 10.1001/jamainternmed.2019.7495.
Reference Type
BACKGROUND
Hranjec T, Rosenberger LH, Swenson B, Metzger R, Flohr TR, Politano AD, Riccio LM, Popovsky KA, Sawyer RG. Aggressive versus conservative initiation of antimicrobial treatment in critically ill surgical patients with suspected intensive-care-unit-acquired infection: a quasi-experimental, before and after observational cohort study. Lancet Infect Dis. 2012 Oct;12(10):774-80. doi: 10.1016/S1473-3099(12)70151-2. Epub 2012 Aug 28.
Reference Type
BACKGROUND
Hoelen DW, Tjan DH, van Vugt R, van der Meer YG, van Zanten AR. Severe local vancomycin induced skin necrosis. Br J Clin Pharmacol. 2007 Oct;64(4):553-4. doi: 10.1111/j.1365-2125.2007.02897.x. Epub 2007 Apr 10. No abstract available.
Reference Type
BACKGROUND
Fridkin SK, Edwards JR, Courval JM, Hill H, Tenover FC, Lawton R, Gaynes RP, McGowan JE Jr; Intensive Care Antimicrobial Resistance Epidemiology (ICARE) Project and the National Nosocomial Infections Surveillance (NNIS) System Hospitals. The effect of vancomycin and third-generation cephalosporins on prevalence of vancomycin-resistant enterococci in 126 U.S. adult intensive care units. Ann Intern Med. 2001 Aug 7;135(3):175-83. doi: 10.7326/0003-4819-135-3-200108070-00009.
Reference Type
BACKGROUND
Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, Nagpal S, Saini V, Srivastava D, Chalmers K, Korenstein D. Evidence for overuse of medical services around the world. Lancet. 2017 Jul 8;390(10090):156-168. doi: 10.1016/S0140-6736(16)32585-5. Epub 2017 Jan 9.
Reference Type
BACKGROUND
Norton WE, Chambers DA, Kramer BS. Conceptualizing De-Implementation in Cancer Care Delivery. J Clin Oncol. 2019 Jan 10;37(2):93-96. doi: 10.1200/JCO.18.00589. Epub 2018 Nov 8. No abstract available.
Reference Type
BACKGROUND
Niven DJ, Mrklas KJ, Holodinsky JK, Straus SE, Hemmelgarn BR, Jeffs LP, Stelfox HT. Towards understanding the de-adoption of low-value clinical practices: a scoping review. BMC Med. 2015 Oct 6;13:255. doi: 10.1186/s12916-015-0488-z.
Reference Type
BACKGROUND
Barlam TF, Childs E, Zieminski SA, Meshesha TM, Jones KE, Butler JM, Damschroder LJ, Goetz MB, Madaras-Kelly K, Reardon CM, Samore MH, Shen J, Stenehjem E, Zhang Y, Drainoni ML. Perspectives of Physician and Pharmacist Stewards on Successful Antibiotic Stewardship Program Implementation: A Qualitative Study. Open Forum Infect Dis. 2020 Jun 15;7(7):ofaa229. doi: 10.1093/ofid/ofaa229. eCollection 2020 Jul.
Reference Type
BACKGROUND
Newland JG, Stach LM, De Lurgio SA, Hedican E, Yu D, Herigon JC, Prasad PA, Jackson MA, Myers AL, Zaoutis TE. Impact of a Prospective-Audit-With-Feedback Antimicrobial Stewardship Program at a Children's Hospital. J Pediatric Infect Dis Soc. 2012 Sep;1(3):179-86. doi: 10.1093/jpids/pis054. Epub 2012 Jul 12.
Reference Type
BACKGROUND
Aizawa Y, Suwa J, Higuchi H, Fukuoka K, Furuichi M, Kaneko T, Morikawa Y, Okazaki K, Shimizu N, Horikoshi Y. Antimicrobial Stewardship Program in a Pediatric Intensive Care Unit. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):e156-e159. doi: 10.1093/jpids/piy031.
Reference Type
BACKGROUND
Cantey JB, Wozniak PS, Pruszynski JE, Sanchez PJ. Reducing unnecessary antibiotic use in the neonatal intensive care unit (SCOUT): a prospective interrupted time-series study. Lancet Infect Dis. 2016 Oct;16(10):1178-1184. doi: 10.1016/S1473-3099(16)30205-5. Epub 2016 Jul 22.
Reference Type
BACKGROUND
Woods-Hill CZ, Fackler J, Nelson McMillan K, Ascenzi J, Martinez DA, Toerper MF, Voskertchian A, Colantuoni E, Klaus SA, Levin S, Milstone AM. Association of a Clinical Practice Guideline With Blood Culture Use in Critically Ill Children. JAMA Pediatr. 2017 Feb 1;171(2):157-164. doi: 10.1001/jamapediatrics.2016.3153.
Reference Type
BACKGROUND
Prusaczyk B, Swindle T, Curran G. Defining and conceptualizing outcomes for de-implementation: key distinctions from implementation outcomes. Implement Sci Commun. 2020 Apr 30;1:43. doi: 10.1186/s43058-020-00035-3. eCollection 2020.
Reference Type
BACKGROUND
Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
Reference Type
BACKGROUND
Lorencatto F, Charani E, Sevdalis N, Tarrant C, Davey P. Driving sustainable change in antimicrobial prescribing practice: how can social and behavioural sciences help? J Antimicrob Chemother. 2018 Oct 1;73(10):2613-2624. doi: 10.1093/jac/dky222.
Reference Type
BACKGROUND
Pandolfo AM, Horne R, Jani Y, Reader TW, Bidad N, Brealey D, Enne VI, Livermore DM, Gant V, Brett SJ; INHALE WP2 Study Group. Understanding decisions about antibiotic prescribing in ICU: an application of the Necessity Concerns Framework. BMJ Qual Saf. 2022 Mar;31(3):199-210. doi: 10.1136/bmjqs-2020-012479. Epub 2021 Jun 7.
Reference Type
BACKGROUND
Wunderink RG, Srinivasan A, Barie PS, Chastre J, Dela Cruz CS, Douglas IS, Ecklund M, Evans SE, Evans SR, Gerlach AT, Hicks LA, Howell M, Hutchinson ML, Hyzy RC, Kane-Gill SL, Lease ED, Metersky ML, Munro N, Niederman MS, Restrepo MI, Sessler CN, Simpson SQ, Swoboda SM, Guillamet CV, Waterer GW, Weiss CH. Antibiotic Stewardship in the Intensive Care Unit. An Official American Thoracic Society Workshop Report in Collaboration with the AACN, CHEST, CDC, and SCCM. Ann Am Thorac Soc. 2020 May;17(5):531-540. doi: 10.1513/AnnalsATS.202003-188ST.
Reference Type
BACKGROUND
Cressman AM, MacFadden DR, Verma AA, Razak F, Daneman N. Empiric Antibiotic Treatment Thresholds for Serious Bacterial Infections: A Scenario-based Survey Study. Clin Infect Dis. 2019 Aug 30;69(6):930-937. doi: 10.1093/cid/ciy1031.
Reference Type
BACKGROUND
Szymczak JE, Muller BM, Shakamuri NS, Hamilton KW, Gerber JS, Laguio-Vila M, Dumyati GK, Fridkin SK, Guh AY, Reddy SC, Lautenbach E; CDC Prevention Epicenters Program. Prescriber perceptions of fluoroquinolones, extended-spectrum cephalosporins, and Clostridioides difficile infection. Infect Control Hosp Epidemiol. 2020 Aug;41(8):914-920. doi: 10.1017/ice.2020.183. Epub 2020 May 29.
Reference Type
BACKGROUND
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U54CK000610-02-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
21-019410
Identifier Type: -
Identifier Source: org_study_id
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