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Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

NCT03687255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2020-03-10

No results posted yet for this study

Summary

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

Conditions

Interventions

DRUG

cefepime/AAI101 combination

cefepime 2 g / AAI101 500 mg

DRUG

Piperacillin/tazobactam

piperacillin 4 GM / tazobactam 500 MG

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Allecra

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2020-01-30
Completion
2020-02-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belarus
  • Bulgaria
  • Croatia
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Lithuania
  • Mexico
  • Peru
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT03687255 on ClinicalTrials.gov