Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01110408 · ClinicalTrials.gov registry record · Phase 3
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT01110408: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT01110408 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110408, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.
Primary Outcome
The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.
Interventions
- DRUG Cefepime
- DRUG Doripenem
- DRUG Cefepime placebo
- DRUG Doripenem placebo
- DRUG Amoxicillin/clavulanate potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
Why NCT01110408 stopped before completion
NCT01110408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Cefepime is the first listed.
NCT01110408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01110408 about?
NCT01110408 is a clinical study titled "A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections". The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.
What is the current status of trial NCT01110408?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2010-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01110408?
The interventions under investigation include: Cefepime (DRUG), Doripenem (DRUG), Cefepime placebo (DRUG), Doripenem placebo (DRUG), Amoxicillin/clavulanate potassium (DRUG).
Who is sponsoring clinical trial NCT01110408?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01110408's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia