NCT02732327

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	CAZ-AVI	Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
DRUG	Vancomycin	15 mg/kg
DRUG	Linezolid	600 mg
DRUG	Cefepime	2 g
DRUG	Meropenem	1 g
DRUG	Piperacillin/tazobactam	4.5 g

Timeline

• Start date: 2016-05-17
• Primary completion: 2016-06-27
• Completion: 2016-06-27
• First posted: 2016-04-08
• Last updated: 2017-07-21
• Results posted: 2017-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study