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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00678106

First received: May 9, 2008

Last updated: October 9, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2008

Last Updated Date

October 9, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00678106 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Bacterial Infections

Intervention ^ICMJE

Drug: Dalbavancin

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

Study Arm (s)

Experimental: 1

Intervention: Drug: Dalbavancin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00678106

Other Study ID Numbers ^ICMJE

A8841004

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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