Can a pharmacist-led vancomycin monitoring and stewardship service improve safe and coordinated vancomycin care in adults at a provincial hospital in Vietnam?
| ISRCTN | ISRCTN10675863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10675863 |
| Institutional scientific-protocol approval | 221/QĐ-BVĐKTG (17/03/2025) |
| Sponsor | Tien Giang General Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 26/08/2026
- Registration date
- 26/08/2026
- Last edited
- 26/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Vancomycin is an antibiotic used to treat serious bacterial infections. Safe and effective use requires careful monitoring because drug exposure that is too high may increase the risk of kidney injury, whereas exposure that is too low may be insufficient for treatment. This study evaluated whether a pharmacist-led vancomycin monitoring and antimicrobial-stewardship service could improve the coordination, reliability and safety of vancomycin care in a provincial hospital in Vietnam.
Who can participate?
Adults aged 18 years or older who started intravenous vancomycin in one of the participating clinical clusters and were expected to receive treatment for at least 48 hours.
What does the study involve?
During usual-care periods, vancomycin prescribing, drug-level monitoring, dose adjustment and kidney-function monitoring followed existing hospital practice. Clinical clusters then moved in a prespecified sequence to a pharmacist-led service. The service coordinated review of the treatment indication, vancomycin dose and infusion, kidney function, drug-level sampling, Bayesian estimation of vancomycin exposure, microbiological results, antimicrobial reassessment and source-control planning. The order in which clinical clusters moved to the service was prespecified for operational purposes and was not randomised. Each participant contributed one treatment episode to the study.
What are the possible benefits and risks of participating?
The service was designed to improve coordination, monitoring and medication safety during vancomycin treatment. The evaluation involved no experimental treatment or additional invasive procedure beyond routine clinical care. The main research-related concern was confidentiality; data used for analysis were de-identified and protected according to institutional requirements.
Where is the study run from?
Tien Giang General Hospital, Vietnam.
When did the study take place?
April 2025 to October 2025.
Who is funding the study?
The study was investigator initiated and self-funded. It received no external research grant or commercial sponsorship.
Who is the main contact?
Nguyen Thanh Nam, MD, PhD. Email: ntnam@tvu.edu.vn
Contact information
Public, Scientific
Tien Giang General Hospital, 315 National Road 1A, Long Hung Quarter, Trung An Ward, Dong Thap Province
Trung An
84118
Viet Nam
 ORCID ID |
0000-0002-1266-2111 |
|---|---|
| Phone | +84 962 479 972 |
| ntnam@tvu.edu.vn |
Principal investigator
Tien Giang General Hospital, 315 National Road 1A, Long Hung Quarter, Trung An Ward, Dong Thap Province
Trung An
84118
Viet Nam
| Phone | +84 273 3872 363 |
|---|---|
| bvdakhoatg@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Prospective, pragmatic, single-centre, non-randomised stepped-wedge implementation study with repeated cross-sectional sampling. Six clinical clusters transitioned sequentially from usual care to the pharmacist-led intervention according to a prespecified operational sequence. The crossover sequence was not randomised and no washout period was used. |
| Purpose | Health services research |
| Scientific title | A prospective non-randomised stepped-wedge study of a pharmacist-led AUC-guided vancomycin stewardship service versus usual care in adults receiving intravenous vancomycin, evaluating early target AUC24 attainment in a provincial referral hospital in Vietnam |
| Study objectives | To evaluate whether implementation of a pharmacist-led AUC-guided vancomycin stewardship service is associated with improved early target AUC24 attainment compared with usual care, and to evaluate excessive vancomycin exposure, acute kidney injury, clinical outcomes, implementation and stewardship processes, and direct hospital resource use. |
| Ethics approval(s) |
Approved 21/03/2025, Biomedical Research Ethics Committee (Institutional Review Board), Tien Giang General Hospital (Tien Giang General Hospital, 315 National Road 1A, Long Hung Quarter, Trung An Ward, Dong Thap Province, Trung An, 84118, Viet Nam; +84 273 3872 363; daotaobvdktg@gmail.com), ref: 232/BVĐKTG-HĐĐĐ |
| Health condition(s) or problem(s) studied | Antimicrobial stewardship and medication safety in adults receiving intravenous vancomycin for serious suspected or confirmed bacterial infection. |
| Intervention | During usual-care periods, intravenous vancomycin prescribing, therapeutic drug monitoring, dose adjustment and renal monitoring followed existing hospital practice. During intervention periods, a pharmacist-led stewardship service integrated review of indication, body weight, renal function and nephrotoxicity risk; loading and maintenance dose review; infusion-rate review; therapeutic-drug-monitoring planning; Bayesian AUC24 estimation and dose optimisation; creatinine surveillance and nephrotoxin review; microbiological sampling before the first dose when feasible; antimicrobial time-out after an actionable microbiological result; de-escalation; and coordination of source control. Six clinical clusters transitioned sequentially from usual care to the intervention according to a prespecified non-randomised operational sequence. Each participant contributed one index treatment episode. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 506 |
| Total final enrolment | 506 |
| Key inclusion criteria | 1. Adults aged 18 years or older, with no protocol-defined upper age limit 2. Male or female 3. Initiation of intravenous vancomycin in a participating clinical cluster 4. Expected vancomycin treatment duration of at least 48 hours |
| Key exclusion criteria | 1. Oral vancomycin or prophylactic use only 2. More than 24 hours of vancomycin therapy before screening 3. Incomplete baseline data 4. Age below 18 years 5. Withdrawal 6. Other prespecified exclusion reasons defined in the approved study protocol |
| Date of first enrolment | 01/04/2025 |
| Date of final enrolment | 27/10/2025 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Trung An
84118
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | De-identified participant-level data, the data dictionary and statistical analysis code may be made available from the corresponding author on reasonable request, subject to institutional, ethics and data-protection approval. The data will not be made publicly available because they originate from clinical records and retain a residual risk of re-identification. |
Editorial Notes
26/08/2026: Trial's existence confirmed by Biomedical Research Ethics Committee (Institutional Review Board), Tien Giang General Hospital.
