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Glycopeptide Antibiotic

Single dose Dalbavancin for Bacterial Infection

Phase 1
Waitlist Available
Research Sponsored by Durata Therapeutics Inc., an affiliate of Allergan plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Bacterial Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
+3 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT03233438
2%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
New Critical Pathway

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single dose DalbavancinExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin
FDA approved

Find a Location

Who is running the clinical trial?

Durata Therapeutics Inc., an affiliate of Allergan plcLead Sponsor
5 Previous Clinical Trials
2,090 Total Patients Enrolled
Michael Dunne, MDStudy DirectorDurata Therapeutics
3 Previous Clinical Trials
1,312 Total Patients Enrolled
~3 spots leftby Nov 2025
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