New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 6, 2002
Last Updated Date	August 13, 2009
Start Date ^ICMJE	February 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 13, 2009)	Investigator's and sponsor's evaluation of patient clinical outcome.
Original Primary Outcome Measures ^ICMJE (submitted: July 2, 2007)	Investigator’s and sponsor’s evaluation of patient clinical outcome.
Change History	Complete list of historical versions of study NCT00035854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 2, 2007)	Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Official Title ^ICMJE	Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
Brief Summary	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Single Group Assignment
Condition ^ICMJE	Bacterial Infections
Intervention ^ICMJE	Drug: Zyvox® / Linezolid
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	May 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Hospitalized/chronic care pediatric patients (birth through 17 years) Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections Requires a minimum of 3 days of IV medication Patients with mixed infections due to VRE & gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required. Exclusion Criteria: Potentially effective concomitant antibiotic A high surgical cure rate Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved) Having an infected device that could not be removed
Gender	Both
Ages	up to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035854
Responsible Party
Study ID Numbers ^ICMJE	M12600082VRE, A5951062
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP