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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03687255

Public ClinicalTrials.gov record NCT03687255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis.

Study identification

NCT ID
NCT03687255
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Allecra
Industry
Enrollment
1,043 participants

Conditions and interventions

Interventions

  • cefepime/AAI101 combination Drug
  • Piperacillin/tazobactam Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 23, 2018
Primary completion
Jan 29, 2020
Completion
Feb 14, 2020
Last update posted
Mar 9, 2020

2018 – 2020

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
St. Josephs Clinical Research Anaheim California 92804
Southbay Pharma Research Buena Park California 90620
Florida Urology Partners Tampa Florida 33615
Washington University School of Medicine St Louis Missouri 63110
Mercury Street Medical Butte Montana 59701
University of New Mexico Health Sciences Center Albuquerque New Mexico 87131

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03687255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 9, 2020 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03687255 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →