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

NCT ID: NCT02732327

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-17
• Study Completion Date: 2016-06-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CAZ-AVI

Intervention Type: DRUG

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

Vancomycin

Intervention Type: DRUG

15 mg/kg

Linezolid

Intervention Type: DRUG

600 mg

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.

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

15 mg/kg

Linezolid

Intervention Type: DRUG

600 mg

Cefepime

Intervention Type: DRUG

2 g

Meropenem

Intervention Type: DRUG

1 g

Piperacillin/tazobactam

Intervention Type: DRUG

4.5 g

Interventions

CAZ-AVI

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

Intervention Type: DRUG

Vancomycin

15 mg/kg

Intervention Type: DRUG

Linezolid

600 mg

Intervention Type: DRUG

Cefepime

2 g

Intervention Type: DRUG

Meropenem

1 g

Intervention Type: DRUG

Piperacillin/tazobactam

4.5 g

Intervention Type: DRUG

Other Intervention Names

Vancocin; Zyvox; Maxipime; Merrem; Zosyn

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Melnick, M.D.

Role: STUDY_DIRECTOR

Allergan

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

CAZ-MD-13

Identifier Type: -

Identifier Source: org_study_id