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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678106
First Posted: May 15, 2008
Last Update Posted: October 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Bacterial Infections Drug: Dalbavancin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR. [ Time Frame: 56 days ]

Secondary Outcome Measures:
  • Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination. [ Time Frame: 56 days ]

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dalbavancin
Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678106


Locations
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00678106     History of Changes
Other Study ID Numbers: A8841004
First Submitted: May 9, 2008
First Posted: May 15, 2008
Last Update Posted: October 12, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
dalbavancin adolescent subjects

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents