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Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

NCT02475733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2018-08-09

Study results available
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Summary

This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam and metronidazole versus meropenem in paediatric population (from 3 months to less than 18 years of age )with complicated intra-abdominal infections (cIAIs)

Conditions

  • Complicated Intra-abdominal Infections

Interventions

DRUG

Ceftazidime -avibactam

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

DRUG

Meropenem

Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment

DRUG

Metronidazole

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

Sponsors & Collaborators

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
2015-08-01
Primary Completion
2017-06-01
Completion
2017-06-01
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT02475733 on ClinicalTrials.gov