Beta-lactam Therapeutic Drug Monitoring in Singapore

NCT04450680 | Unknown

• 1 other identifier: BLAST-2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• proportion of patients achieving beta-lactam therapeutic targets

  proportion of patients achieving beta-lactam therapeutic targets

  until end of beta-lactam therapy, an average of 2 weeks

Interventions

Beta-lactam Therapeutic Drug Monitoring OTHER

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

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the above-mentioned hospital and receiving beta-lactam therapy

You may qualify if:

• Adult patients (21 years and above)
• Admitted to Singapore General Hospital
• Receiving beta-lactam therapy for documented or suspected infection
• Indication for beta-lactam therapeutic drug monitoring: critically ill, altered pharmacokinetics (burns, obese, on extracorporeal therapy, dialysis), immunocompromised, resistant pathogens, deep-seated infections, suspected or at risk for adverse effects

You may not qualify if:

• Expected mortality within next 24 hours
• Pregnancy

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (4)

• Huttner A, Harbarth S, Hope WW, Lipman J, Roberts JA. Therapeutic drug monitoring of the beta-lactam antibiotics: what is the evidence and which patients should we be using it for? J Antimicrob Chemother. 2015 Dec;70(12):3178-83. doi: 10.1093/jac/dkv201. Epub 2015 Jul 17.

  PMID: 26188037 BACKGROUND

• Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, Kaukonen KM, Koulenti D, Martin C, Montravers P, Rello J, Rhodes A, Starr T, Wallis SC, Lipman J; DALI Study. DALI: defining antibiotic levels in intensive care unit patients: are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014 Apr;58(8):1072-83. doi: 10.1093/cid/ciu027. Epub 2014 Jan 14.

  PMID: 24429437 BACKGROUND

• Roberts JA, Ulldemolins M, Roberts MS, McWhinney B, Ungerer J, Paterson DL, Lipman J. Therapeutic drug monitoring of beta-lactams in critically ill patients: proof of concept. Int J Antimicrob Agents. 2010 Oct;36(4):332-9. doi: 10.1016/j.ijantimicag.2010.06.008. Epub 2010 Aug 3.

  PMID: 20685085 BACKGROUND

• Heffernan AJ, Sime FB, Lipman J, Roberts JA. Individualising Therapy to Minimize Bacterial Multidrug Resistance. Drugs. 2018 Apr;78(6):621-641. doi: 10.1007/s40265-018-0891-9.

  PMID: 29569104 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Nathalie Chua

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Chua

CONTACT

63213752; nathalie.grace.sy.chua@sgh.com.sg

Andrea Kwa

CONTACT

63266959; andrea.kwa.l.h@sgh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 29, 2020
• Study Start: October 10, 2019
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)