Antibiotic Outbreak, Risk Factors for Never Event, Prediction of Inappropriate Use

NCT03489330 | Completed

• 1 other identifier: MWU3004_STU00205629
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

In order to decrease inappropriate antibiotic use, drivers of inappropriate use must be identified locally. This study will focus on the MOST inappropriate use, which are defined as 'never events'. Previous work has shown that antibiotic use clusters over time. It is hypothesized that never events also cluster over time. Using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Conditions

Infectious Disease

Keywords

Anti-Bacterial Agents/therapeutic use; Drug Utilization/statistics & numerical data; Hospitals/statistics & numerical data; Data Analysis, Statistical; Interpretation, Statistical Data; Antibiotic Stewardship; Electronic Medical Record

Outcome Measures

Primary Outcomes (1)

• appropriateness of vancomycin use

  classified as 1) never event, 2) potentially inappropriate, 3) not inappropriate

  Proposed 36 month study period

Secondary Outcomes (1)

• outbreaks of never events

  Proposed 36 month study period

Study Arms (3)

Northwestern Memorial Hospital data

Inpatient intravenous vancomycin use

Henry Ford Hospital data

Inpatient intravenous vancomycin use

University of Michigan Hospital data

Inpatient intravenous vancomycin use

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective study population will be based on all inpatient intravenous vancomycin used during the proposed 36-month study period. Patient level data that identifies adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will not be collected.

You may qualify if:

• receipt of inpatient intravenous vancomycin during proposed study period
• adults 18 years of age or older and less than 90 years of age

You may not qualify if:

• individuals who are not yet adults (infants, children, teenagers)
• pregnant women
• prisoners

Sponsors & Collaborators

• Midwestern University: lead
• Northwestern Memorial Hospital: collaborator
• University of Michigan: collaborator
• Henry Ford Hospital: collaborator
• Wayne State University: collaborator

Study Sites (1)

Midwestern University

Downers Grove, Illinois, 60515, United States

Location

Related Publications (13)

• Scheetz MH, Crew PE, Miglis C, Gilbert EM, Sutton SH, O'Donnell JN, Postelnick M, Zembower T, Rhodes NJ. Investigating the Extremes of Antibiotic Use with an Epidemiologic Framework. Antimicrob Agents Chemother. 2016 May 23;60(6):3265-9. doi: 10.1128/AAC.00572-16. Print 2016 Jun.

  PMID: 27001807 BACKGROUND

• P.R. Yarnold, R.C. Soltysik, Refining two-group multivariable classification models using univariate optimal discriminant analysis., Decision Sciences, 22 (1991) 1158-1164.

  BACKGROUND

• P.R. Yarnold, R.C. Soltysik, Maximizing Predictive Accuracy, ODA Books2016.

  BACKGROUND

• Rhodes NJ, O'Donnell JN, Lizza BD, McLaughlin MM, Esterly JS, Scheetz MH. Tree-Based Models for Predicting Mortality in Gram-Negative Bacteremia: Avoid Putting the CART before the Horse. Antimicrob Agents Chemother. 2015 Nov 23;60(2):838-44. doi: 10.1128/AAC.01564-15. Print 2016 Feb.

  PMID: 26596934 BACKGROUND

• Cusini A, Rampini SK, Bansal V, Ledergerber B, Kuster SP, Ruef C, Weber R. Different patterns of inappropriate antimicrobial use in surgical and medical units at a tertiary care hospital in Switzerland: a prevalence survey. PLoS One. 2010 Nov 16;5(11):e14011. doi: 10.1371/journal.pone.0014011.

  PMID: 21103362 BACKGROUND

• Glowacki RC, Schwartz DN, Itokazu GS, Wisniewski MF, Kieszkowski P, Weinstein RA. Antibiotic combinations with redundant antimicrobial spectra: clinical epidemiology and pilot intervention of computer-assisted surveillance. Clin Infect Dis. 2003 Jul 1;37(1):59-64. doi: 10.1086/376623. Epub 2003 Jun 23.

  PMID: 12830409 BACKGROUND

• Hecker MT, Aron DC, Patel NP, Lehmann MK, Donskey CJ. Unnecessary use of antimicrobials in hospitalized patients: current patterns of misuse with an emphasis on the antianaerobic spectrum of activity. Arch Intern Med. 2003 Apr 28;163(8):972-8. doi: 10.1001/archinte.163.8.972.

  PMID: 12719208 BACKGROUND

• Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.

  PMID: 27139059 BACKGROUND

• Kelesidis T, Braykov N, Uslan DZ, Morgan DJ, Gandra S, Johannsson B, Schweizer ML, Weisenberg SA, Young H, Cantey J, Perencevich E, Septimus E, Srinivasan A, Laxminarayan R. Indications and Types of Antibiotic Agents Used in 6 Acute Care Hospitals, 2009-2010: A Pragmatic Retrospective Observational Study. Infect Control Hosp Epidemiol. 2016 Jan;37(1):70-9. doi: 10.1017/ice.2015.226. Epub 2015 Oct 12.

  PMID: 26456803 BACKGROUND

• Magill SS, Edwards JR, Beldavs ZG, Dumyati G, Janelle SJ, Kainer MA, Lynfield R, Nadle J, Neuhauser MM, Ray SM, Richards K, Rodriguez R, Thompson DL, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Prevalence of antimicrobial use in US acute care hospitals, May-September 2011. JAMA. 2014 Oct 8;312(14):1438-46. doi: 10.1001/jama.2014.12923.

  PMID: 25291579 BACKGROUND

• Baggs J, Fridkin SK, Pollack LA, Srinivasan A, Jernigan JA. Estimating National Trends in Inpatient Antibiotic Use Among US Hospitals From 2006 to 2012. JAMA Intern Med. 2016 Nov 1;176(11):1639-1648. doi: 10.1001/jamainternmed.2016.5651.

  PMID: 27653796 BACKGROUND

• Rhodes NJ, Wagner JL, Gilbert EM, Crew PE, Davis SL, Scheetz MH. Days of Therapy and Antimicrobial Days: Similarities and Differences Between Consumption Metrics. Infect Control Hosp Epidemiol. 2016 Aug;37(8):971-973. doi: 10.1017/ice.2016.109. Epub 2016 May 13.

  PMID: 27174570 BACKGROUND

• The World Health Organization. Health Topics: Disease Outbreaks, 2015.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc H Scheetz, PharmD, MSc

  Midwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: April 5, 2018
• Study Start: January 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 29, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)