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Antimicrobial StewardshipEQUIPS-ICUNCT06666738

Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)

An observational study of Antimicrobial Stewardship, run by University of Oxford at 1 site in Vietnam.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The goal of this observational study is to learn about the implementation of a process to review antimicrobial prescriptions for adult patients in Intensive Care Unit (ICU). The main question it aims to answer is: can a structured antimicrobial review can be implemented in ICUs? Implementation will be supported by the… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Antimicrobial Stewardship
What is being tested?
Structured antimicrobial review
How many people
6,300 participants
Where
1 siteVietnam
Study dates
13 Jan 2025to 31 Dec 2026
Phase
Observational

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All adult ICUs within CCAA-affiliated CQRs, where surveillance of antimicrobial utilisation has already been established will be considered for participation. ICUs must appoint a named Champion in order to participate. A survey will be conducted to determine pre-existing prescribing practice and the presence, characteristics and current adoption of structured review activities. Pre-existing antimicrobial review processes are neither a requirement for an ICU to participate nor an exclusion criterion. Instead, parallel to the survey, pre-implementation patient-level data pertaining to current antimicrobial prescribing review practices will be measured during months 1-2. ICU's which are found to already have a structured antimicrobial review in place, and which demonstrate adoption and reach of 80% or greater (median over the 2 months) will not be eligible to participate in the implementation to reduce confounding of the selected measures for implementation success.

Who may be able to join

  • All adult ICUs within CCAA-affiliated Care Quality Registries
  • ICUs must appoint a named Champion to facilitate implementation
  • All antimicrobial prescriptions for adult patients within the ICUs described above

Who cannot join

  • ICU's which demonstrate adoption and reach of 80% or greater (median over 2 months) of a pre-existing structured antimicrobial review

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Duncan Wagstaff, PhD contact

0044(0)2076799060

d.wagstaff@ucl.ac.uk

Arjen Dondorp, Prof contact

arjen@tropmedres.ac

Vietnam1 site, 1 recruiting
  • National Hospital for Tropical Diseases

    Hanoi, Hanoi, 123000

    Louise Thwaites

    Yen Lam Minh

    Recruiting

Other trials in Vietnam

About this study

Official title: Evidence Based QUality Improvement for Prescribing Stewardship in ICU: Can a Structured Antimicrobial Review be Implemented in LMIC ICUs?

The goal of this observational study is to learn about the implementation of a process to review antimicrobial prescriptions for adult patients in Intensive Care Unit (ICU).

The main question it aims to answer is: can a structured antimicrobial review can be implemented in ICUs?

Implementation will be supported by the use of local protocols, audit and feedback, and education. It will be evaluated by daily data collection of clinical processes and interviews with local champions.

Resources to conduct the study are provided by the Wellcome Flagship Innovations award. ("Collaboration for Research, Implementation and Training in Critical Care in Asia and Africa", reference 224048/Z/21/Z).

Being tested
Structured antimicrobial review
Keywords
Critical care, Antimicrobial Stewardship, Implementation, Quality improvement, Low or Middle Income Country (LMIC)

What participants receive

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

  • Structured antimicrobial reviewBehavioural

    The appropriateness of the documented indication, route of administration, expected duration and stop date of all antimicrobials will be reviewed within 48 hours of their prescription.

What is being measured

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

  1. Fidelity

    The proportion of prescriptions reviewed as intended (reviewed within 48hours with documentation of all 4 review components: indication, route, duration, stop date). Reported as a proportion of the number of possible reviews.

    Measured: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)

  2. Reach

    Proportion of eligible patients who receive a review

    Measured: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)

  3. Adoption

    Proportion of prescriptions reviewed as intended once implementation support has been withdrawn

    Measured: Evaluated over the calendar month period of month 7

Secondary outcomes (5)
  1. Antimicrobial Density (AD)

    Defined Daily Dose / 1000 patient-days. This measure of antimicrobial consumption will compare prescribed daily doses of antimicrobials to those specified by the World Health Organization (WHO) (Anatomical Therapeutic Classification (ATC) J01 Defined Daily Doses). To correct for ICU unit size the investigators will standardise by number of admitted patient-days during that month in that ICU.

    Measured: Evaluated over calendar month periods during months 1-7 of the study.

  2. Duration of Therapy

    Number of Days of antimicrobial Therapy / 1000 patient-days Analysed at the ICU level

    Measured: Evaluated over calendar month periods during months 1-7 of the study

  3. Antimicrobial Redundancy Rate

    Days of Therapy of prespecified redundant combinations of antimicrobials. Analysed at the ICU level.

    Measured: Evaluated over calendar month periods during months 1-7 of the study

  4. Antimicrobial resistance rate

    Number of multidrug-resistant pathogens (as specified by WHO priority list) / number of patients

    Measured: Evaluated over calendar month periods during months 1-7 of the study

  5. Antimicrobial prescribing rate

    Number of patients receiving at least 1 antimicrobial / number of patients admitted to ICU in the same period

    Measured: Evaluated over calendar month periods during months 1-7 of the study

Timeline

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

  1. First posted31 Oct 2024
  2. Study start13 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Prospective
Enrolment
6,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666738
Sponsor's protocol ID
HCR24005 (559-24)
Acronym
EQUIPS-ICU
Status last verified
Oct 2026
First submitted
23 Oct 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: With participants' consent, as per the record of verbal consent, de-identified data may be uploaded to data repositories or shared with other researchers in line with MORU's data sharing policy.

Publications

  • Wagstaff D, Amuasi J, Arfin S, Aryal D, Nor MBM, Bonney J, Dondorp A, Dongelmans D, Dullawe L, Fazla F, Ghose A, Hanciles E, Haniffa R, Hashmi M, Smith AH, Kumar B, Minh YL, Moonesinghe R, Pisani L, Sendagire C, Hasan MS, Ghalib MS, Frimpong MS, Ranzani O, Sultan M, Thomson D, Tripathy S, Thwaites L, Uddin RAME, Mazlan MZ, Waweru-Siika W, Beane A. Evidence based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU): protocol for type III hybrid implementation-effectiveness study. Implement Sci. 2025 Feb 25;20(1):12. doi: 10.1186/s13012-024-01413-4.

    PubMed 40001051

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