NCT02837081

Brief Summary

Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes. Two core strategies of ASP recommended as effective in guidelines are formulary restriction with drug preauthorization and prospective audit with feedback. Investigators will evaluate the effectiveness of the 2 strategies using antimicrobial utilization and patient outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

December 1, 2015

Last Update Submit

July 14, 2016

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (2)

  • Antimicrobial utilization using defined daily dose (DDD)

    Defined daily dose (DDD),

    4 weeks

  • Antimicrobial utilization using defined daily dose per 1000 patient days (DID)

    Defined daily dose per 1000 patient days

    4 weeks

Secondary Outcomes (2)

  • Appropriateness of antimicrobial prescription by susceptibility of culture

    4 weeks

  • Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians

    4 weeks

Other Outcomes (4)

  • 30-day mortality

    30 days post randomization

  • 3-day defervescence rate

    3 day post randomization

  • Rate of hospital associated bloodstream infections

    12 months

  • +1 more other outcomes

Study Arms (2)

Preauthorization group

ACTIVE COMPARATOR

Strategy 1 of antimicrobial stewardship: Prescriptions of antimicrobial agents are done real-time by infectious diseases physician consultant. Use restricted without real-time authorization.

Other: preauthorization strategy of antimicrobial stewardship

Prospective audit

EXPERIMENTAL

Strategy 2 of antimicrobial stewardship: Prescription of antimicrobial agents are audited 48-72 hours later by infectious diseases physician consultant. Use allowed without authorization for 72 hours.

Other: Prospective audit strategy of antimicrobial stewardship

Interventions

Prospective audit strategy of antimicrobial stewardshipOTHER

applying prospective audit as a different strategy of antimicrobial stewardship

Also known as: prospective audit
Prospective audit
preauthorization strategy of antimicrobial stewardshipOTHER

applying preauthorization as one strategy of antimicrobial stewardship

Also known as: preauthorization
Preauthorization group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In-hospital patients, aged 20 and above, with request from managing physicians for use of restricted antimicrobials.

You may not qualify if:

  • Patients admitted to the intensive care unit at evaluation or within 48 hours of entry into the study.
  • Patients with antimicrobial prescriptions prescribed during after-hours, including weekends and public holidays.
  • Formal infectious disease consultations requested prior to randomization.
  • Patients in the emergency department and outpatient department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

RECRUITING

Related Publications (12)

  • Society for Healthcare Epidemiology of America; Infectious Diseases Society of America; Pediatric Infectious Diseases Society. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS). Infect Control Hosp Epidemiol. 2012 Apr;33(4):322-7. doi: 10.1086/665010.

    PMID: 22418625RESULT

  • W.H.O. (2011) WHO Global Strategy for Containment of Antimicrobial Resistance.

    RESULT

  • Tseng SH, Lee CM, Lin TY, Chang SC, Chuang YC, Yen MY, Hwang KP, Leu HS, Yen CC, Chang FY. Combating antimicrobial resistance: antimicrobial stewardship program in Taiwan. J Microbiol Immunol Infect. 2012 Apr;45(2):79-89. doi: 10.1016/j.jmii.2012.03.007. Epub 2012 Apr 5.

    PMID: 22483434RESULT

  • Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.

    PMID: 17173212RESULT

  • Chung GW, Wu JE, Yeo CL, Chan D, Hsu LY. Antimicrobial stewardship: a review of prospective audit and feedback systems and an objective evaluation of outcomes. Virulence. 2013 Feb 15;4(2):151-7. doi: 10.4161/viru.21626. Epub 2013 Jan 9.

    PMID: 23302793RESULT

  • Lin YS, Lin IF, Yen YF, Lin PC, Shiu YC, Hu HY, Yang YP. Impact of an antimicrobial stewardship program with multidisciplinary cooperation in a community public teaching hospital in Taiwan. Am J Infect Control. 2013 Nov;41(11):1069-72. doi: 10.1016/j.ajic.2013.04.004. Epub 2013 Jul 17.

    PMID: 23870295RESULT

  • Teng CB, Ng TM, Tan MW, Tan SH, Tay M, Lim SF, Ling LM, Ang BS, Lye DC. Safety and effectiveness of improving carbapenem use via prospective review and feedback in a multidisciplinary antimicrobial stewardship programme. Ann Acad Med Singap. 2015 Jan;44(1):19-25.

    PMID: 25703493RESULT

  • Reed EE, Stevenson KB, West JE, Bauer KA, Goff DA. Impact of formulary restriction with prior authorization by an antimicrobial stewardship program. Virulence. 2013 Feb 15;4(2):158-62. doi: 10.4161/viru.21657. Epub 2012 Nov 15.

    PMID: 23154323RESULT

  • Mehta JM, Haynes K, Wileyto EP, Gerber JS, Timko DR, Morgan SC, Binkley S, Fishman NO, Lautenbach E, Zaoutis T; Centers for Disease Control and Prevention Epicenter Program. Comparison of prior authorization and prospective audit with feedback for antimicrobial stewardship. Infect Control Hosp Epidemiol. 2014 Sep;35(9):1092-9. doi: 10.1086/677624. Epub 2014 Jul 23.

    PMID: 25111916RESULT

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716RESULT

  • W.H.O. Defined Daily Dose (DDD). 2015 [cited 2015 May 24]; Available from: http://www.whocc.no/ddd/definition_and_general_considera/.

    RESULT

  • van den Bosch CM, Geerlings SE, Natsch S, Prins JM, Hulscher ME. Quality indicators to measure appropriate antibiotic use in hospitalized adults. Clin Infect Dis. 2015 Jan 15;60(2):281-91. doi: 10.1093/cid/ciu747. Epub 2014 Sep 28.

    PMID: 25266285RESULT

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Susan Shin-Jung Lee, M.D., Ph.D.

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Shin-Jung Lee, M.D., Ph.D.

CONTACT

+886-7-342-2121ssjlee28@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 1, 2015

First Posted

July 19, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

TW(1)