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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02732327
• Other study ID #: CAZ-MD-13
• Status: Terminated
• Phase: Phase 2
• First received: March 18, 2016
• Last updated: September 9, 2016
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neoplasms
• Neutropenia

Intervention

Drug:
• CAZ-AVI
Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
• Vancomycin
15 mg/kg
• Linezolid
600 mg
• Cefepime
2 g
• Meropenem
1 g
• Piperacillin/tazobactam
4.5 g

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) in the Modified Intent-to-Treat (MITT) Analysis Set	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.	Up to Day 14	No
Secondary	Percentage of Participants with Favorable Clinical Response at EOIV in the Microbiological MITT (mMITT)	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.	Up to Day 14	No
Secondary	Percentage of Participants with Favorable Clinical Response at EOIV in the Clinically Evaluable (CE) Analysis Set	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.	Up to Day 14	No
Secondary	Percentage of Participants with Favorable Clinical Response at Test of Cure (TOC) and Late-Follow-Up (LFU) in the MITT Analysis Set	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.	TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Favorable Clinical Response by Baseline Gram-negative Pathogen at EOIV, TOC, and LFU in the mMITT Analysis Set	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.	EOIV: Up to Day 14; TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Favorable Clinical Response by Baseline Gram-negative Pathogen at EOIV, TOC, and LFU in the CE Analysis Set	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.	EOIV: Up to Day 14; TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Favorable Microbiological Response by Baseline Gram-negative Pathogen at EOIV, TOC, and LFU in the mMITT Analysis Set	Favorable microbiological response is defined as eradication (pathogen absent in the source specimen) or presumed eradication (sustained resolution of all acute signs and symptoms of primary infection) of the original pathogen.	EOIV: Up to Day 14; TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Favorable Microbiological Response by Baseline Gram-negative Pathogen at EOIV, TOC, and LFU in the Microbiologically Evaluable (ME) Analysis Set	Favorable microbiological response is defined as eradication (pathogen absent in the source specimen) or presumed eradication (sustained resolution of all acute signs and symptoms of primary infection) of the original pathogen.	EOIV: Up to Day 14; TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Infection-related Mortality at TOC and LFU in the MITT Analysis Set		TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with Infection-related Mortality at TOC and LFU in the mMITT Analysis Set		TOC: Days 21-28; LFU: Days 35-42	No
Secondary	Percentage of Participants with 30-Day All-Cause Mortality in the MITT Analysis Set		Up to Day 30	No
Secondary	Percentage of Participants with 30-Day All-Cause Mortality in the mMITT Analysis Set		Up to Day 30	No