AzTrials
AzTrials

Infectious DiseaseNCT03489330

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

An observational study of Infectious Disease, run by Midwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Infectious Disease
Type of treatment
Injection or infusion
How many people
2,000 participants
Where
1 siteUnited States
Study dates
1 Jan 2014to 29 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Midwestern University

    Downers Grove, Illinois, 60515

Other trials in United States

About this study

Official title: A Retrospective Study to Understand the Risk Factors/Drivers of "Inappropriate" Antimicrobial Use and the Performance Evaluation of a Clinical Decision Support Tool That Facilitates Prediction of Outbreaks of Inappropriate Antibiotic Use

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.

Read the detailed description

Appropriateness in antimicrobial prescribing has become a focal national and international issue. It has been estimated that upwards of 50% of antibiotic use is inappropriate. With this backdrop, a national strategic goal has been set by the United States White House to decrease inappropriate antibiotic use by 20% and 50%, respectively for inpatient and outpatient settings. In order to decrease inappropriate use, drivers of incorrect use must be identified at each local setting. The actual drivers of confirmed inappropriate use have been difficult to identify except when using time and resource intense chart reviews. Even the largest contemporary antibiotic consumption studies have not assessed appropriateness as it was 'outside of study scope'. Further, there is no consensus or agreement on what constitutes inappropriate use. These apparent omissions underscore the difficulty and complexity in attributing appropriateness of use for antimicrobials. Importantly, 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.

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
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03489330
Study groupRoleWhat they receive
Northwestern Memorial Hospital dataInpatient intravenous vancomycin use
Henry Ford Hospital dataInpatient intravenous vancomycin use
University of Michigan Hospital dataInpatient intravenous vancomycin use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. appropriateness of vancomycin use

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

    Measured: Proposed 36 month study period

Secondary outcomes (1)

  1. outbreaks of never events

    predictive interval thresholds that identify high proportion of never events

    Measured: Proposed 36 month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start1 Jan 2014
  3. Primary completion1 Oct 2017
  4. Study completion29 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03489330
Sponsor's protocol ID
MWU3004_STU00205629
Status last verified
Mar 2021
First submitted
18 Mar 2018
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All files containing patient identifiers will be de-identified before sharing across study sites.

Publications

  • 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.

    PubMed 27001807

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

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

  • 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.

    PubMed 26596934

  • 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.

    PubMed 21103362

  • 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.

    PubMed 12830409

  • 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.

    PubMed 12719208

  • 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.

    PubMed 27139059

  • 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.

    PubMed 26456803

  • 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.

    PubMed 25291579

  • 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.

    PubMed 27653796

  • 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.

    PubMed 27174570

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

Questions about this trial

What is this clinical trial studying?

An observational study of Infectious Disease, run by Midwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

appropriateness of vancomycin use (time frame: Proposed 36 month study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03489330, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in