Back to resultsComparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
Primary Purpose
Neoplasms, Febrile Neutropenia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAZ-AVI
Vancomycin
Linezolid
Cefepime
Meropenem
Piperacillin/tazobactam
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms
Eligibility Criteria
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.
Sites / Locations
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAZ-AVI + Vancomycin or Linezolid
Standard of Care+Vancomycin or Linezolid
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02732327
Brief Title
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
No longer aligned with the revised clinical development plan and commercial strategy
Study Start Date
May 17, 2016 (Actual)
Primary Completion Date
June 27, 2016 (Actual)
Study Completion Date
June 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Febrile Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAZ-AVI + Vancomycin or Linezolid
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care+Vancomycin or Linezolid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CAZ-AVI
Intervention Description
Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
15 mg/kg
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
600 mg
Intervention Type
Drug
Intervention Name(s)
Cefepime
Other Intervention Name(s)
Maxipime
Intervention Description
2 g
Intervention Type
Drug
Intervention Name(s)
Meropenem
Other Intervention Name(s)
Merrem
Intervention Description
1 g
Intervention Type
Drug
Intervention Name(s)
Piperacillin/tazobactam
Other Intervention Name(s)
Zosyn
Intervention Description
4.5 g
Primary Outcome Measure Information:
Title
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Melnick, M.D.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
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