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A comparison of clinical response of vancomycin plus piperacillin/tazobactam and vancomycin plus meropenem empiric therapy in non-critically ill hemodialysis patients with suspected central line-associated bloodstream infections: an open-label, randomized controlled trial

A comparison of clinical response of vancomycin plus piperacillin/tazobactam and vancomycin plus meropenem empiric therapy in non-critically ill hemodialysis patients with suspected central line-associated bloodstream infections: an open-label, randomized controlled trial

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240917008
Enrollment
120
Registered
2024-09-17
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empiric therapy in non-critically ill hemodialysis patients with suspected central line-associated bloodstream infections Central line-associated bloodstream infections, empiric treatment, mortality

Interventions

Vancomycin - Loading dose: 20-30 mg/kg (maximum 3 gm) infused intravenously at rate of 10-15 mg/min - Maintenance dose 15-20 mg/kg then adjust by vancomycin trough level (pre-hemodialysis) Piperacill
Active Comparator Drug,Active Comparator Drug
Vancomycin plus piperacillin-tazobactam,Vancomycin plus meropenem

Sponsors

Faculty of medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 20 years old or more, 2. Clinically suspected CLABSI and aim to empirical treatment as CLABSI decided by physician, 3. Hemodialysis patients who had hemodialysis catheter at any sites (both tunneled and non-tunneled catheter, both Long term and short-term catheter), 4. Patients provide informed consent

Exclusion criteria

Exclusion criteria: 1. Critically ill patients (NEWS score 7 or more), 2. Admission to critical care unit, 3. Severe allergy to antimicrobial regimen, 4. Had prior culture result within 6 months with pathogens where study drugs cannot be used e.g. VRE, CRE, ESBL-producing organisms, MDR-A. baumannii, MDR P. aeruginosa, 5. Exit-site infection, tunnel infection without suspected CLABSI, 6. Refuse to participate in the study

Design outcomes

Primary

MeasureTime frame
Clinical response 7 days Clinical response define as resolution of sign and symptom of infection, eg. BT less than 37.8c, sterilization of blood culture within 7 days of treatment

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactWorawut Worawutwittaya

Faculty of medicine, Chiang Mai University

worawut.wo@cmu.ac.th6653936457

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026