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

NCT ID: NCT00678106

Last Updated: 2009-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Dalbavancin

Intervention Type DRUG

Subjects weighing \> 60 Kg: 1 gram IV single dose Subjects weighing \< 60 Kg: 15 mg/Kg IV

Interventions

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Dalbavancin

Subjects weighing \> 60 Kg: 1 gram IV single dose Subjects weighing \< 60 Kg: 15 mg/Kg IV

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A8841004

Identifier Type: -

Identifier Source: org_study_id

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