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

NCT02732327 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CAZ-MD-13
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Neoplasms; Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CAZ-AVI + Vancomycin or Linezolid

EXPERIMENTAL

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; Drug: Vancomycin; Drug: Linezolid

Standard of Care+Vancomycin or Linezolid

ACTIVE COMPARATOR

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; Drug: Linezolid; Drug: Cefepime; Drug: Meropenem; Drug: Piperacillin/tazobactam

Interventions

CAZ-AVI DRUG

Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)

CAZ-AVI + Vancomycin or Linezolid

Vancomycin DRUG

15 mg/kg

Also known as: Vancocin

CAZ-AVI + Vancomycin or Linezolid; Standard of Care+Vancomycin or Linezolid

Linezolid DRUG

600 mg

Also known as: Zyvox

CAZ-AVI + Vancomycin or Linezolid; Standard of Care+Vancomycin or Linezolid

Cefepime DRUG

2 g

Also known as: Maxipime

Standard of Care+Vancomycin or Linezolid

Meropenem DRUG

1 g

Also known as: Merrem

Standard of Care+Vancomycin or Linezolid

Piperacillin/tazobactam DRUG

4.5 g

Also known as: Zosyn

Standard of Care+Vancomycin or Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
• Requires hospitalization for intravenous (IV) empiric antibiotic therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Febrile Neutropenia

Interventions

Vancomycin; Linezolid; Cefepime; Meropenem; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thienamycins; Carbapenems; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfones; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: David Melnick, MD
• Organization: Allergan

Melnick_David@Allergan.com

201-427-8554

Study Officials

• David Melnick, M.D.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 8, 2016
• Study Start: May 17, 2016
• Primary Completion: June 27, 2016
• Study Completion: June 27, 2016
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)