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

NCT01946568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-06-23

No results posted yet for this study

Summary

A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

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.

Sponsors & Collaborators

  • Durata Therapeutics Inc., an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Michael Dunne, MD · Durata Therapeutics

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Estonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01946568 on ClinicalTrials.gov