Terminated PHASE3 INTERVENTIONAL 2-arm NCT01110408

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections

A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections

Sponsor: Janssen Research & Development, LLC

Conditions Complicated Urinary Tract Infections or Pyelonephritis

Interventions Amoxicillin/clavulanate potassium Cefepime Cefepime placebo Doripenem Doripenem placebo

Updated 9 times since 2017 Last updated: Jul 2, 2014 Started: Dec 31, 2010 Primary completion: Jun 30, 2013 Completion: Jun 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Trial terminated early per business decision

Other terminated trials from Janssen Research & Development, LLC

More terminations from Janssen Research & Development, LLC

This PHASE3 trial investigates Complicated Urinary Tract Infections or Pyelonephritis and is currently terminated or withdrawn. Janssen Research & Development, LLC leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

9 versions recorded

Nov 2025 — Present [monthly]

Terminated PHASE3
Sep 2025 — Nov 2025 [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Dec 2021 — Jul 2024 [monthly]

Terminated PHASE3

▶ Show 4 earlier versions

Jan 2021 — Dec 2021 [monthly]

Terminated PHASE3
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE3
Feb 2017 — Jun 2018 [monthly]

Terminated PHASE3
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE3

First recorded

Dec 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen Research & Development, LLC

Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Belo Horizonte, Brazil , Bogotá, Colombia , Buenos Aires, Argentina , Cali, Colombia , Caxias do Sul, Brazil , Cleveland, United States , Córdoba, Argentina , Floridablanca, Colombia , Guadajalara, Mexico and 28 more locations