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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
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 moreSide effects data
From 2018 Phase 4 trial • 91 Patients • NCT032334382%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,365,789 Total Patients Enrolled