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Lipoglycopeptide Antibiotic

Dalbavancin for Staphylococcus Aureus Bacteremia

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an IV antibiotic on patients with complicated bacterial infections caused by Staphylococcus aureus who have cleared their initial infection. The antibiotic works by killing or stopping the growth of bacteria to prevent the infection from coming back.

Eligible Conditions

Staph Bacteraemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Desirability of Outcome Ranking (DOOR)

Secondary study objectives

Frequency of AEs Leading to Study Drug Discontinuation

Frequency of AEs Leading to Study Drug Discontinuation (A Component of DOOR)

Frequency of All-Cause Mortality (A Component of DOOR)

+5 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT03233438

Hypoglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Usual Care

New Critical Pathway

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (Dalbavancin)Experimental Treatment1 Intervention

Dalbavancin 1500 mg will be administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for subjects with Creatinine Clearance (CrCl) \<30 and not on dialysis. N=100

Group II: Arm 2 (Standard of Care)Active Control5 Interventions

For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks OR cefazolin (2 g will be administrated intravenously (IV) every 8 hours for 4-6 weeks) For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg will be administrated intravenously (IV) daily for 4-6 weeks). N=100

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalbavancin

2014

Completed Phase 4

~2250

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