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

Phase 1

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Dalbavancin

• Registration Number: NCT00678106
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-15
• Study Start: 2008-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-09
• Last Update Posted: 2009-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

• Patients being treated with vancomycin.
• Patients with liver and kidney failure.
• Pregnant female subjects.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Dalbavancin	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cleveland, Ohio, United States