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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678106
• Other study ID #: A8841004
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2008
• Last updated: October 9, 2009
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bacterial Infections
• Infection

Intervention

Drug:
• Dalbavancin
Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR.		56 days	No
Secondary	Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination.		56 days	No

External Links

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