New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
NCT00035854
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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
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| 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 | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Bacterial Infections | ||
| Intervention ICMJE | Drug: Zyvox® / Linezolid | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 13 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Actual Study Completion Date ICMJE | May 2004 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | up to 17 Years (Child) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00035854 | ||
| Other Study ID Numbers ICMJE | M12600082VRE A5951062 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | August 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||