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

• Status: Terminated
• Trial end date: 2016-06-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Avibactam; Avibactam, ceftazidime drug combination; Cefepime; Ceftazidime; Linezolid; Meropenem; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam; Vancomycin

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.