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Beta-lactam Therapeutic Drug Monitoring in Singapore

NCT04450680 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-04-14

No results posted yet for this study

Summary

This is a prospective cohort study to evaluate clinical utility and feasibility of beta-lactam therapeutic drug monitoring in Singapore. The investigators hypothesise that conventional beta-lactam dosing regimens based on manufacturer's recommendations (derived from Phase I studies on healthy volunteers) will produce sub-optimal levels in at least half of the patients. Hence, beta-lactam therapeutic drug monitoring and dose individualisation will be required for optimal clinical outcomes. The investigators' secondary aims include correlating various therapeutic targets with clinical outcomes to identify a suitable therapeutic target for clinical use and to characterise beta-lactam pharmacokinetics in sub-group of patients with complex pharmacokinetics so that local empirical dosing regimens can be formulated.

Conditions

  • Infection, Bacterial

Interventions

OTHER

Beta-lactam Therapeutic Drug Monitoring

Monitoring serum beta-lactam levels to individualise beta-lactam doses and ensure therapeutic target attainment

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Nathalie Chua · Singapore General Hospital

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450680 on ClinicalTrials.gov