A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Bacterial Infections.
Interventions
DRUG

Dalbavancin

Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients \<5 years of age.

Trial Locations (12)

10032

Columbia University, New York

13419

Tallin's Children Hospital Pediatric Clinic, Tallinn

27710

Duke Medical Center, Durham

40202

University of Louisville, Louisville

43606

Pediatric Pharmacology, Toledo

48109

University of Michigan Medical Center, Ann Arbor

51015

Tartu University Hospital Anesthesiology & Intensive Care, Tartu

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

72202

University Arkansas Medical Center, Little Rock

77030

Texas Children's Hospital - Clinical Care Center, Houston

92123

University of California, San Diego, San Diego

06106

Connecicut Children's Hospital, Hartford

All Listed Sponsors
lead

Durata Therapeutics Inc., an affiliate of Allergan plc

INDUSTRY

NCT01946568 - A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years. | Biotech Hunter | Biotech Hunter