Febrile Neutropenia, Neoplasms
Conditions
Brief summary
This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer
Interventions
DRUGCAZ-AVI
Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
DRUGVancomycin
15 mg/kg
DRUGLinezolid
600 mg
DRUGCefepime
2 g
DRUGMeropenem
1 g
DRUGPiperacillin/tazobactam
4.5 g
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation * Requires hospitalization for intravenous (IV) empiric antibiotic therapy
Exclusion criteria
* Fungal or viral infection requiring additional therapy * Known acute viral hepatitis * Known to be human immunodeficiency virus (HIV) positive * Expected requirement for hemodialysis while on study therapy * Received \>24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug * Past or current history of epilepsy or seizure disorder * Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Up to Day 14 | Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed. |
Countries
United States
Participant flow
Recruitment details
The planned sample size was 100 patients; however, the sponsor discontinued the study due to the fact that the study no longer aligned with the revised clinical development plan and commercial strategy for CAZ-AVI. A total of 2 patients were enrolled and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| CAZ-AVI + Vancomycin or Linezolid Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care \[SOC\]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug. | 0 |
| Standard of Care+Vancomycin or Linezolid Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care+Vancomycin or Linezolid | Total |
|---|---|---|
| Age, Customized Between 18 and 65 years | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 2 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
Primary
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.
Time frame: Up to Day 14