ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12618000110280

Ethics application status

Approved

Date submitted

27/07/2015

Date registered

24/01/2018

Date last updated

24/01/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Beta-lactam pharmacokinetics in haematology patients with sepsis.

Scientific title

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.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Febrile neutropenia

Haematological malignancy

Sepsis

Condition category

Condition code

Infection

Studies of infection and infectious agents

Cancer

Leukaemia - Acute leukaemia

Cancer

Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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 survival. The maximum period of observation will be 30 days.
3. Assessment of changes in creatinine clearance with the onset of sepsis, using timed urine collection before and after onset of fever.

Intervention code [1]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The achievement of target serum beta-lactam concentrations as measured by the time during the dosing interval for which the unbound antibiotic concentration remains above the desired minimum inhibitory concentration (fTMIC).

Timepoint [1]

Two samples collected in steady state (ie at least 24 hours after commencing antibiotic): one at mid-dosing interval and one at end of dosing interval.

Secondary outcome [1]

Creatinine clearance at baseline and following the onset of sepsis, calculated using paired serum and 24 hour urine samples.

Timepoint [1]

At enrolment and again at onset of first fever.

Secondary outcome [2]

Time to resolution of infection, defined by time to normalisation of temperature and haemodynamic parameters. This information will be collected from the patient's hospital record.

Timepoint [2]

Days from time of first fever. This information will be collected from the patient's hospital record.

Secondary outcome [3]

Duration of antibiotic treatment. This information will be collected from the patient's hospital record.

Timepoint [3]

Days from time of initiation of antibiotic. This information will be collected from the patient's hospital record.

Secondary outcome [4]

Duration of in-patient hospital stay. This information will be collected from the patient's hospital record.

Timepoint [4]

Days from time of first fever to discharge. This information will be collected from the patient's hospital record.

Secondary outcome [5]

Overall survival. This information will be collected from the patient's hospital record.

Timepoint [5]

30 days from time of first fever. This information will be collected from the patient's hospital record.

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

6/08/2015

Date of last participant enrolment

Anticipated

Actual

20/02/2017

Date of last data collection

Anticipated

Actual

20/03/2017

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

RBWH Foundation

Address [1]

Block 20 Royal Brisbane and Women’s Hospital
Butterfield St
Herston QLD 4006

Country [1]

Australia

Primary sponsor type

Hospital

Name

Cancer Care Services, RBWH

Address

Level 5
Joyce Twedell Bldg
Royal Brisbane Hospital
Butterfield St
Herston QLD 4006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RBWH HREC

Ethics committee address [1]

Human Research Ethics Office
Level 7, Block 7
Royal Brisbane and Women's Hospital
Herston Rd
Herston QLD 4006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/04/2015

Ethics approval number [1]

HREC/15/QRBW/104

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicholas Weber

Address

Level 5 Joyce Twedell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4006

Country

Australia

Phone

+61736468111

Fax

nicholas.weber@health.qld.gov.au

Contact person for public queries

Name

Nicholas Weber

Address

Level 5 Joyce Twedell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4006

Country

Australia

Phone

+61736468111

Fax

nicholas.weber@health.qld.gov.au

Contact person for scientific queries

Name

Nicholas Weber

Address

Level 5 Joyce Twedell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4006

Country

Australia

Phone

+61736468111

Fax

nicholas.weber@health.qld.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluation of pharmacokinetic/pharmacodynamic and clinical outcomes with 6-hourly empiric piperacillin-tazobactam dosing in hematological malignancy patients with febrile neutropenia.	2019	https://dx.doi.org/10.1016/j.jiac.2019.02.014

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically