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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00678106
Other study ID # A8841004
Secondary ID
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


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
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