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

Last updated on March 14, 2019

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Study Location
Research Center
Long Beach, California, 90806 United States
Contact
1-800-718-1021
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.
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- 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.
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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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