Therapeutic drug monitoring guided dose optimization of beta-lactam antibiotics in haematology/oncology patients with febrile neutropenia

Phase 2

Completed

• Conditions: Febrile neutropenia; haematological malignancies; Infection - Other infectious diseases; Cancer - Leukaemia - Acute leukaemia; Blood - Haematological diseases

• Registration Number: ACTRN12615000086561
• Lead Sponsor: Therapeutics Research Centre, University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

diagnosis of febrile neutropenia, diagnosis of cancer or hematological malignancy, prescribed to receive a beta-lactam antibiotics, ability to get prior informed consent

Exclusion Criteria

know or suspected allergy to the study antibiotics, pregnancy, inability to get informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attainment of pharmacokinetic/pharmacodynamic target (100%fT>MIC). This will be determined by using the trough concentration measured from venous blood samples in reference to MIC breakpoints. Local institutional antibiograms at the study hospital or European Committee on Antimicrobial Susceptibility Testing (EUCAST) (http://www.eucast.org/clinical breakpoints) recommendations will be used as reference bacterial susceptibility breakpoints. Note that the trough concentration monitoring allows determination of this outcome measure with out determining the actual time the free drug concentration remains above MIC. [Baseline and the following two consecutive days ]

Secondary Outcome Measures

Name	Time	Method
Duration of fever defined as as the time between commencement of antibiotic treatment immediately after diagnosis of febrile neutropenia and the first day of at least 2 consecutive days that temperature will be less than 38 degree celsius. This will be assessed by recording daily core body temperature from patients medical chart measured using clinical thermometers. [during antibiotic treatment ]