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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03869437




Registration number
NCT03869437
Ethics application status
Date submitted
6/02/2019
Date registered
11/03/2019
Date last updated
13/02/2024

Titles & IDs
Public title
RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI
Scientific title
Investigator Driven Randomized Controlled Trial of Cefiderocol Versus Standard Therapy for Healthcare Associated and Hospital Acquired Gram-negative Blood Stream Infection: Study Protocol (the GAME CHANGER Trial)
Secondary ID [1] 0 0
GAME CHANGER
Universal Trial Number (UTN)
Trial acronym
GAMECHANGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bloodstream Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cefiderocol
Other interventions - Best Available Therapy

Experimental: Cefiderocol - Participants will receive Cefiderocol 2 grams administered intravenously over 3 hours, every 8 hours for a minium of 5 days and a maximun of 14 days.

Active comparator: Best Available Therapy (BAT) - BAT will be chosen by the investigator and intravenously administered per country-specific guidelines.


Treatment: Drugs: Cefiderocol
2 grams intravenously administered over 3 hours every 8 hours for a period of 5 to 14 days (dosage adjustment is necessary based on renal function).

Other interventions: Best Available Therapy
Standard of care was determined by the investigator
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality at 14 days
Timepoint [1] 0 0
14 days post date of randomisation
Secondary outcome [1] 0 0
Mortality post blood stream infection of each regimen at longer time points
Timepoint [1] 0 0
30 and 90 days, from day of randomisation or "day 1"
Secondary outcome [2] 0 0
Clinical and microbiological failure at day 14
Timepoint [2] 0 0
Day 14, from day of randomisation or "day 1"
Secondary outcome [3] 0 0
Microbiological failure days 3 to 90 post randomisation
Timepoint [3] 0 0
Day 3 through to day 90
Secondary outcome [4] 0 0
Colonisation or infection with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), carbapenem-resistant Gram-negative bacilli or Candida bloodstream infection.
Timepoint [4] 0 0
Day 3 through to day 90
Secondary outcome [5] 0 0
Clostridioides di?cile infection days 3 to 90 post randomisation.
Timepoint [5] 0 0
Day 3 through to day 90
Secondary outcome [6] 0 0
Improvement in functional status at day 30 post randomisation compared to baseline.
Timepoint [6] 0 0
Day 30, from day of randomisation or "day 1"
Secondary outcome [7] 0 0
Time to hospital discharge.
Timepoint [7] 0 0
From day of randomisation or "day 1" through to day 90
Secondary outcome [8] 0 0
Treatment emergent SAEs (Serious Adverse Events)
Timepoint [8] 0 0
From day of randomisation or "day 1" through to 5 days post end of study treatment.

Eligibility
Key inclusion criteria
1. Bloodstream infection with a Gram-negative organism from at least one blood culture draw. Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2).
2. The blood stream infection fulfils the criteria as a hospital acquired or healthcare associated infection as per the following definitions:

1. Hospital acquired - Blood stream infection occurring greater than 48 hours after hospital admission, assessed as symptoms or signs of infection not present at time of hospital admission.
2. Healthcare associated - Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following criteria:

i. Participant has an intravascular catheter/line that is the source of infection ii. Attended a hospital or haemodialysis clinic or received intravenous chemotherapy in the previous 30 days iii. were hospitalized in an acute care hospital for two or more days in the previous 90 days iv. resided in a nursing home or long-term care facility v. received intravenous antibiotic therapy at home, wound care or specialized nursing care through a healthcare agency, family or friends; or had self-administered intravenous antibiotic medical therapy in the 30 days before the infection
3. No more than 48 hours has elapsed since the positive blood culture collection.
4. Participant is aged 18 years and over (21 in Singapore)
5. The participant or approved proxy is able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Refractory shock or comorbid condition such that patient not expected to survive more than 7 days.
2. Participant with history of moderate to severe hypersensitivity reaction to a cephalosporin.
3. Participant with significant polymicrobial bacteraemia including a significant Gram-positive pathogen (that is, a Gram-positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
4. Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed.
5. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
6. Known pregnancy or breast-feeding.
7. Participant is receiving peritoneal dialysis.
8. Participant previously randomised in this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2024
Sample size
Target
Accrual to date
Final
513
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Brisbane and Womens Hospital - Brisbane
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [5] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Malaysia
State/province [1] 0 0
Kelantan
Country [2] 0 0
Malaysia
State/province [2] 0 0
Kuala Lumpur
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taichung
Country [5] 0 0
Taiwan
State/province [5] 0 0
Tainan
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taipei
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taoyuan
Country [8] 0 0
Thailand
State/province [8] 0 0
Bangkok
Country [9] 0 0
Thailand
State/province [9] 0 0
Khon Kaen
Country [10] 0 0
Turkey
State/province [10] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Shionogi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Paterson, Professor
Address 0 0
The Univeristy of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/37/NCT03869437/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03869437