Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-10-10
2022-06-30
Brief Summary
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Detailed Description
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The investigators propose a prospective cohort study on adult patients (≥21 years) admitted to SGH. Four blood samples will be obtained over a dosing interval and assayed using liquid chromatography with tandem mass spectrometry. Levels and dose adjustment recommendations will be reported to physicians by infectious disease pharmacists.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Beta-lactam Therapeutic Drug Monitoring
Monitoring serum beta-lactam levels to individualise beta-lactam doses and ensure therapeutic target attainment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pregnancy
21 Years
99 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Nathalie Chua
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BLAST-2
Identifier Type: -
Identifier Source: org_study_id
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