Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

Study Overview
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Brief Summary
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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

Official Title
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A Single-Center, Randomized, Open-label, Prospective, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Vancomycin or Linezolid Versus Standard of Care Plus Vancomycin or Linezolid as Empiric Therapy in Febrile Neutropenic Adults With Cancer

Conditions
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Neoplasms, Febrile Neutropenia

Intervention / Treatment
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* Drug: CAZ-AVI
* Drug: Vancomycin
* Drug: Linezolid
* Drug: Cefepime
* Drug: Meropenem
* Drug: Piperacillin/tazobactam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAZ-AVI + Vancomycin or Linezolid<br>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. | Drug: CAZ-AVI<br>* Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)<br>Drug: Vancomycin<br>* 15 mg/kg<br>* Other names: Vancocin;Drug: Linezolid<br>* 600 mg<br>* Other names: Zyvox;|
| Active Comparator: Standard of Care+Vancomycin or Linezolid<br>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. | Drug: Vancomycin<br>* 15 mg/kg<br>* Other names: Vancocin;Drug: Linezolid<br>* 600 mg<br>* Other names: Zyvox;Drug: Cefepime<br>* 2 g<br>* Other names: Maxipime;Drug: Meropenem<br>* 1 g<br>* Other names: Merrem;Drug: Piperacillin/tazobactam<br>* 4.5 g<br>* Other names: Zosyn;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Day 14 |