Beta-lactam pharmacokinetics in haematology patients with sepsis.

Evaluation of pharmacokinetic and clinical outcomes with standard empiric beta-lactam antibiotic dosing strategies in patients with febrile neutropenia being treated with intensive chemotherapy for haematological malignancies, including assessment of alterations in renal clearance in the setting of sepsis.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618000110280

Enrollment

Registered

2018-01-24

Start date

2015-08-06

Completion date

2017-02-20

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic outcomes with standard beta lactam antibiotics given to patients with febrile neutropenia as a result of intensive chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have been prescribed a course of intensive chemotherapy for acute leukaemia or high-grade lymphoma. Study details This is an observational study, so all participants will undergo the standard care prescribed to them by their treating physician. To assess outcomes, blood samples will be taken at baseline, two samples approximately 24 hours after commencement of antibiotics and at onset of fever, and one urine sample will also be taken 24 hours after onset of fever. Additional information including length of antibiotic use and hospital stay will also be noted. It is hoped that the findings of this trial will aid understanding of the distribution and levels of this class of antibiotics in the body, and their impact on outcomes in patients with febrile neutropenia as a result of intensive chemotherapy.

Interventions

1. Assessment of pharmacokinetic/pharmacodynamic outcomes of beta lactam antibiotics which are prescribed in the course of standard care of neutropenic fever. Specifically, two drug levels will be collected in steady-state to calculate the time during the dosing interval for which the unbound antibiotic concentration remains above the desired MIC. 2. Assessment of clinical outcomes, including rate of resolution of infection, duration of antibiotic treatment, length of hospital stay, overall surv

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Able to provide written informed consent; Age equal to or greater than 18 years; Receiving intensive chemotherapy for acute leukaemia or high-grade lymphoma -Intensive chemotherapy is defined as a treatment regimen that is expected to produce neutropenia (absolute neutrophil count <1x10^9/L) for at least 7 days duration.

Exclusion criteria

Inadequate venous access to facilitate sample collection; Pre-existing renal failure (eGFR <60mL/min); Known allergy/ hypersensitivity to all study beta-lactam antibiotics; Prior anaphylaxis to penicillin; Pregnancy.

Outcome results