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Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)

NCT02497781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-07-11

Study results available
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Summary

This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with complicated urinary tract infections.

Conditions

  • Complicated Urinary Tract Infections

Interventions

DRUG

Ceftazidime -avibactam

Patients randomised (3:1) to the CAZ-AVI or cefepime treatment

DRUG

Cefepime

Patients randomised (3:1) to the CAZ-AVI or cefepime treatment

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2017-09-15
Completion
2017-09-15
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Greece
  • Hungary
  • Poland
  • Romania
  • Russia
  • Taiwan
  • Turkey (Türkiye)

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 NCT02497781 on ClinicalTrials.gov