Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections

NARecruitingINTERVENTIONAL
Enrollment

810

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
SepsisHemodynamic InstabilityBacterial InfectionsTherapeutic Drug MonitoringAntimicrobial Resistance
Interventions
OTHER

Therapeutic Drug Monitoring (TDM)

Upon randomization and before the bacterial culture results are known, blood sampling will be obtained from the patient during the morning round of initial empiric antibiotic administration. PK/PD target analysis based on the clinical susceptibility breakpoints of Enterobacterales (the most prevalent organism family of DT-GNB infections in our setting) will be performed and a dosage recommendation will be communicated to the primary ID clinician. Antibiotic dosing adjustments (if any) will be made within 8 - 24 hours of the blood sampling by the Primary / Infectious Diseases clinician. In case of inappropriate dosing, where the PK/PD target is not achieved or exceeded with antibiotic side effects observed, the dosage will be increased or decreased, respectively.

Trial Locations (1)

168582

RECRUITING

Singapore General Hospital, Singapore

All Listed Sponsors
lead

Singapore General Hospital

OTHER