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Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections

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NCT00678106

Last updated on May 10, 2018
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Study Location
Pfizer Investigational Site
San Diego, California, 92123 United States
See other locations
Contact
1-800-718-1021
[email protected]
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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
12-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections.

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

- Patients being treated with vancomycin.

- Patients with liver and kidney failure.

- Pregnant female subjects.

NCT00678106
Pfizer
Completed
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections

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Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Dalbavancin In Hospitalized Adolescents, Aged 12 Through 17 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections
Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. Safety labs will also be checked on a regular basis to assess the safety of dalbavancin.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Bacterial Infections
Drug: Dalbavancin
Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV
Experimental: 1
Intervention: Drug: Dalbavancin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections.

Exclusion Criteria:

  • Patients being treated with vancomycin.
  • Patients with liver and kidney failure.
  • Pregnant female subjects.
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00678106
A8841004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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