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Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

NCT01644643 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2017-09-29

Study results available
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Summary

To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

Conditions

  • Complicated Urinary Tract Infection
  • Complicated Intra-abdominal Infection

Interventions

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

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

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

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Paul Newell, MBBS, MRCP · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Israel
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644643 on ClinicalTrials.gov