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

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ClinicalTrials.gov Identifier: NCT02732327
Recruitment Status : Terminated (No longer aligned with the revised clinical development plan and commercial strategy)
First Posted : April 8, 2016
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Neoplasms Febrile Neutropenia Drug: CAZ-AVI Drug: Vancomycin Drug: Linezolid Drug: Cefepime Drug: Meropenem Drug: Piperacillin/tazobactam Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : June 27, 2016
Actual Study Completion Date : June 27, 2016


Arm Intervention/treatment
Experimental: 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.
Drug: CAZ-AVI
Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)

Drug: Vancomycin
15 mg/kg
Other Name: Vancocin

Drug: Linezolid
600 mg
Other Name: Zyvox

Active Comparator: 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.
Drug: Vancomycin
15 mg/kg
Other Name: Vancocin

Drug: Linezolid
600 mg
Other Name: Zyvox

Drug: Cefepime
2 g
Other Name: Maxipime

Drug: Meropenem
1 g
Other Name: Merrem

Drug: Piperacillin/tazobactam
4.5 g
Other Name: Zosyn




Primary Outcome Measures :
  1. Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732327


Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: David Melnick, M.D. Allergan

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02732327     History of Changes
Other Study ID Numbers: CAZ-MD-13
First Posted: April 8, 2016    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Vancomycin
Linezolid
Meropenem
Tazobactam
Piperacillin
Cefepime
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors