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

Forest Laboratories

Status and phase: Terminated; Phase 2

Conditions: Febrile Neutropenia; Neoplasms

Treatments: Drug: Vancomycin; Drug: Meropenem; Drug: CAZ-AVI; Drug: Cefepime; Drug: Piperacillin/tazobactam; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02732327

CAZ-MD-13

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

CAZ-AVI + Vancomycin or Linezolid

Experimental group

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.

Treatment:

Drug: Linezolid

Drug: CAZ-AVI

Drug: Vancomycin

Standard of Care+Vancomycin or Linezolid

Active Comparator group

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.

Treatment:

Drug: Linezolid

Drug: Piperacillin/tazobactam

Drug: Cefepime

Drug: Meropenem

Drug: Vancomycin