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



Status:Not yet recruiting
Conditions:Cancer, Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2016
End Date:November 2017
Contact:Clinical Trial Registry Team
Email:IR-CTRegistration@allergan.com
Phone:1-800-347-4500

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
1
site
M.D. Anderson Cancer Center
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials