Terminated PHASE3 INTERVENTIONAL 2-arm NCT01110421

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

Sponsor: Janssen Research & Development, LLC

Conditions Community-Acquired Infections Nosocomial Infection Pneumonia, Bacterial Pneumonia, Ventilator-Associated

Interventions Amoxicillin/clavulanate potassium Cefepime Cefepime placebo Doripenem Doripenem placebo

Updated 12 times since 2017 Last updated: Jul 2, 2014 Started: Dec 31, 2010 Primary completion: Mar 31, 2012 Completion: Mar 31, 2012

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

A PHASE3 clinical study on Community-Acquired Infections and Nosocomial Infection, this trial is terminated or withdrawn. The trial is conducted by Janssen Research & Development, LLC and has accumulated 12 data snapshots since 2010. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

12 versions recorded

Nov 2025 — Present [monthly]

Terminated PHASE3
Oct 2025 — Nov 2025 [monthly]

Terminated PHASE3
Sep 2025 — Oct 2025 [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3

▶ Show 7 earlier versions

Jan 2023 — Jul 2024 [monthly]

Terminated PHASE3
Dec 2022 — Jan 2023 [monthly]

Terminated PHASE3
Dec 2021 — Dec 2022 [monthly]

Terminated PHASE3
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

Belo Horizonte, Brazil , Bogotá, Colombia , Buenos Aires, Argentina , Cali, Colombia , Cleveland, United States , Córdoba, Argentina , Guadajalara, Mexico , Kaunas, Lithuania , Kharkiv, Ukraine , Little Rock, United States and 15 more locations