Comparative Study of Ceftazidime-Avibactam Versus Standar... | NCT02732327

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAZ-AVI + Vancomycin or Linezolid	Experimental	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.	Drug: CAZ-AVI Drug: Vancomycin Drug: Linezolid
Standard of Care+Vancomycin or Linezolid	Active Comparator	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.	Drug: Vancomycin Drug: Linezolid Drug: Cefepime Drug: Meropenem Drug: Piperacillin/tazobactam

Name	Type	Description	Arm Group Labels	Other Names
CAZ-AVI	Drug	Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)	CAZ-AVI + Vancomycin or Linezolid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)	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. Due to study termination and limited enrollment, outcome measures were not analyzed.	Up to Day 14

Eligibility Module

Name	Affiliation	Role
David Melnick, M.D.	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0000 BG0012 BG0022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0010 BG0020
Male

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)

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. Due to study termination and limited enrollment, outcome measures were not analyzed.

Posted

Up to Day 14

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0000 OG0010

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			0	0	0	0
EG001	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.			0	2	2	2

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected0 at risk EG0011 affected2 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected0 at risk EG0011 affected2 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected0 at risk EG0011 affected2 at risk

Title	Organization	Phone	Extension	Email
David Melnick, MD	Allergan	201-427-8554		Melnick_David@Allergan.com

ID	Term
D009369	Neoplasms
D064147	Febrile Neutropenia

ID	Term
D009503	Neutropenia
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007960	Leukocyte Disorders

ID	Term
D014640	Vancomycin
D000069349	Linezolid
D000077723	Cefepime
D000077731	Meropenem
D000077725	Piperacillin, Tazobactam Drug Combination

Ancestor Terms

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D023303	Oxazolidinones
D010080	Oxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D013845	Thienamycins
D015780	Carbapenems
D000078142	Tazobactam
D010397	Penicillanic Acid
D010406	Penicillins
D010878	Piperacillin
D000667	Ampicillin
D010400	Penicillin G
D013450	Sulfones
D004338	Drug Combinations
D004364	Pharmaceutical Preparations