Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00678106
First received: May 9, 2008
Last updated: October 9, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infections |
Drug: Dalbavancin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 10 |
| Study Start Date: | September 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dalbavancin
Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV
|
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678106
Locations
| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00678106 History of Changes |
| Other Study ID Numbers: | A8841004 |
| Study First Received: | May 9, 2008 |
| Last Updated: | October 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
dalbavancin adolescent subjects |
Additional relevant MeSH terms:
|
Bacterial Infections Dalbavancin Teicoplanin Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013