NCT00678106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

May 9, 2008

Last Update Submit

October 9, 2009

Conditions

Bacterial Infections

Keywords

dalbavancin adolescent subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: Dalbavancin

Interventions

DalbavancinDRUG

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

1

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Related Links

MeSH Terms

Conditions

Bacterial Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 15, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

US(3)