- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00678106
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
October 9, 2009 updated by: Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40202
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44106
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
May 9, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (Estimate)
May 15, 2008
Study Record Updates
Last Update Posted (Estimate)
October 12, 2009
Last Update Submitted That Met QC Criteria
October 9, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A8841004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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GlaxoSmithKlineWithdrawn
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Durata Therapeutics Inc., an affiliate of Allergan...CompletedBacterial Infections.United States, Estonia
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Correvio International SarlPrimeVigilance; AMS Advanced Medical Services GmbHTerminated
-
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