Ceftazidime-Avibactam for the treatment of infections due to Ceftazidime Resistant Pathogens

Study identifier:D4280C00006

ClinicalTrials.gov identifier:NCT01644643

EudraCT identifier:2012-000726-21

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

Medical condition

Complicated Urinary Tract Infection,

Phase

Phase 3

Healthy volunteers

Study drug

Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy, Metronidazole

Sex

All

Actual Enrollment

345

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 01 Jan 2013

Primary Completion Date: 01 Sept 2014

Study Completion Date: 01 Sept 2014

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2016 by AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Ceftazidime - Avibactam ( CAZ-AVI) IV treatment	Drug: Ceftazidime - Avibactam ( CAZ-AVI) Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes Drug: Metronidazole Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion Other Name: Flagyl
Active Comparator: Best Available Therapy IV treatment	Drug: Best Available Therapy Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation

Arms

Assigned Interventions

Experimental: Ceftazidime - Avibactam ( CAZ-AVI)
IV treatment

Drug: Ceftazidime - Avibactam ( CAZ-AVI)
Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes

Drug: Metronidazole
Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion

Other Name: Flagyl

Active Comparator: Best Available Therapy
IV treatment

Drug: Best Available Therapy
Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation

Documents available

D4280C00006 Clinical Study Protocol
Download
D4280C00006 Clinical Study Protocol Amendment 2 Redacted amended
Download
D4280C00006 Clinical Study Protocol Amendment 3 Redacted amended
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Leslie Smith

1-910-313-1583

[email protected]

Investigators

Principal Investigator

Paul Newell

AstraZeneca LP