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
Effectiveness Progress
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
This is further along than 68% of similar trials
Side Effects for
Usual Care
2%Hypoglycaemia
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: DrugArm 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.
References
- Turner, Nicholas A., Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, et al.. 2022. “Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): Study Protocol for a Phase 2b, Multicenter, Randomized, Open-label Clinical Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06370-1.
- 2021. "DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04775953.
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Conditions
Cancer Related
Treatments