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.
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
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6,300 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Arjen Dondorp, Prof contact
Vietnam1 site, 1 recruiting
- Recruiting
National Hospital for Tropical Diseases
Hanoi, Hanoi, 123000
Louise Thwaites
Yen Lam Minh
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).
- Conditions
- Antimicrobial Stewardship
- 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.
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)
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)
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)
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.
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
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
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
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.
- First posted31 Oct 2024
- Study start13 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial StewardshipStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Nat Intensive Care Surveillence-MORU
- Responsible party
- Sponsor
- Investigators
- Abi Beane, Dr., Principal investigator, University of Oxford
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based QUality Improvement for Prescribing Stewardship in ICU: Can a Structured Antimicrobial Review be Implemented in LMIC ICUs?
- ClinicalTrials.gov ID
- NCT06666738
- Acronym / sponsor ID
- EQUIPS-ICU / HCR24005 (559-24)
- Conditions
- Antimicrobial Stewardship
- Keywords
- Critical care, Antimicrobial Stewardship, Implementation, Quality improvement, Low or Middle Income Country (LMIC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Nat Intensive Care Surveillence-MORU
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- ICU's which demonstrate adoption and reach of 80% or greater (median over 2 months) of a pre-existing structured antimicrobial review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured antimicrobial reviewThe 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. | Behavioural | – |
Primary outcome
Fidelity
Time frame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)
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.
Reach
Time frame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)
Proportion of eligible patients who receive a review
Adoption
Time frame: Evaluated over the calendar month period of month 7
Proportion of prescriptions reviewed as intended once implementation support has been withdrawn
5 secondary outcomes
Antimicrobial Density (AD)
Time frame: Evaluated over calendar month periods during months 1-7 of the study.
Duration of Therapy
Time frame: Evaluated over calendar month periods during months 1-7 of the study
Antimicrobial Redundancy Rate
Time frame: Evaluated over calendar month periods during months 1-7 of the study
Antimicrobial resistance rate
Time frame: Evaluated over calendar month periods during months 1-7 of the study
Antimicrobial prescribing rate
Time frame: Evaluated over calendar month periods during months 1-7 of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 40001051Wagstaff 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.
- Individual participant dataSharing planned: 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.
Related trials for Antimicrobial Stewardship
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjen Dondorp, Prof contact
Abi Beane, Dr. principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Stewardship, run by University of Oxford at 1 site in Vietnam.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duncan Wagstaff, PhD (0044(0)2076799060, d.wagstaff@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity (time frame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)). The study lists 3 primary outcomes in all. 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 NCT06666738, which also lists 1 linked publication.
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 7 Oct 2026.