Ceftazidime-Avibactam compared with Doripenem Followed by Oral Therapy for hospitalized adults with complicated UTIs (Urinary Tract Infections)

Study identifier:D4280C00002

ClinicalTrials.gov identifier:NCT01595438

EudraCT identifier:2011-005721-43

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Medical condition

Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Phase

Phase 3

Healthy volunteers

Study drug

Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Sex

All

Actual Enrollment

598

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 01 Oct 2012

Primary Completion Date: 01 Aug 2014

Study Completion Date: 01 Aug 2014

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria

Location

Research Site

Cordoba, Argentina

Location

Research Site

Córdoba, Argentina

Location

Research Site

Santa Fe, Argentina

Location

Research Site

Mendoza, Argentina

Location

Research Site

Salvador, Brazil

Location

Research Site

Belo Horizonte, Brazil

Location

Research Site

São Paulo, Brazil

Location

Research Site

Vila Clementino, Brazil

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: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Active Comparator: Doripenem IV treatment	Drug: Doripenem 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

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: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Active Comparator: Doripenem
IV treatment

Drug: Doripenem
500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes

Documents available

D4280C00002 RECAPTURE 1 CSP amendment 3 09Aug2013 Redacted final MH
Download
D4280C00002 RECAPTURE 1_CSP edition 1_14Feb2012 Redacted_final MH
Download
D4280C00002 RECAPTURE 1_CSP_amendment 1_8May2012 Redacted_final MH
Download
D4280C00002 RECAPTURE 1_CSP_amendment 2_21Aug2012 Redacted_final MH
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Arvil Stephens

1-910-558-7573

Arvil.Stephens@ppdi.com

Investigators

Principal Investigator

Paul Newell

AstraZeneca LP

Ceftazidime-Avibactam compared with Doripenem Followed by Oral Therapy for hospitalized adults with complicated UTIs (Urinary Tract Infections)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

D4280C00002 RECAPTURE 1 CSP amendment 3 09Aug2013 Redacted final MH

D4280C00002 RECAPTURE 1_CSP edition 1_14Feb2012 Redacted_final MH

D4280C00002 RECAPTURE 1_CSP_amendment 1_8May2012 Redacted_final MH

D4280C00002 RECAPTURE 1_CSP_amendment 2_21Aug2012 Redacted_final MH

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator