Dalbavancin for Staph Bacteraemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Staph BacteraemiaDalbavancin - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the antibiotic dalbavancin is better than a standard antibiotic regimen at treating bacteremia or right-sided native valve infective endocarditis caused by S. aureus. 200 subjects will be randomly assigned to receive either dalbavancin or the standard antibiotic regimen, and the primary objective is to compare the two treatments at Day 70.

Eligible Conditions
  • Staph Bacteraemia

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Day 1 through Day 180

Day 180
Incidence of all-cause mortality
Proportion of participants who experienced a clinical efficacy of antibiotic therapy
Proportion of participants who experienced any adverse event (AE) leading to study drug discontinuation
Proportion of participants who experienced any serious adverse event (SAE) leading to study drug discontinuation
Proportion of participants who experienced clinical success of antibiotic therapy
Proportion of participants with infectious complications
Day 70
Desirability of Outcome Ranking (DOOR) for the treatment of subjects with complicated Staphylococcus aureus bacteremia

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Usual Care
2%Hypoglycaemia
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03233438) in the Usual Care ARM group. Side effects include: Hypoglycaemia with 2%.

Trial Design

2 Treatment Groups

Arm 2 (Standard of Care)
1 of 2
Arm 1 (Dalbavancin)
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Dalbavancin · No Placebo Group · Phase 2

Arm 1 (Dalbavancin)
Drug
Experimental Group · 1 Intervention: Dalbavancin · Intervention Types: Drug
Arm 2 (Standard of Care)ActiveComparator Group · 5 Interventions: Cefazolin, Nafcillin, Oxacillin, Daptomycin, Vancomycin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through day 180

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,151 Previous Clinical Trials
4,770,674 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received written informed consent from the patient or legally authorized representative before the initiation of any study-specific procedures.
You are treated with an effective antibiotic therapy for at least 72 hours (maximum 10 days).
You have a minimum platelet count of at least 100,000 per microlitre of blood, which is slightly below the typical healthy range.
You must be willing and able, if discharged, to return to the hospital or designated clinic for scheduled treatment, laboratory tests, or other procedures as required by the protocol.
Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.