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

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NCT00035854

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Research Center
Long Beach, California, 90806 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-17
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

further examination by the investigator is necessary.

NCT00035854
Pfizer
Completed
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)

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Pfizer Clinical Trials Contact Center

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[email protected]

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New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bacterial Infections
Drug: Zyvox® / Linezolid
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2004
Not Provided

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
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00035854
M12600082VRE
A5951062
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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