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A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age

NCT01366651 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-12-06

No results posted yet for this study

Summary

The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients \<1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.

Conditions

Interventions

DRUG

Doripenem

Type=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to \<1 year of age.

DRUG

Doripenem

Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients \<12 weeks of age.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Development, L.L.C., Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Belgium

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 NCT01366651 on ClinicalTrials.gov