DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
Public ClinicalTrials.gov record NCT04775953. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated S. Aureus Bacteremia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline bacteremia. Approximately 200 subjects will be randomized 1:1 to receive either dalbavancin or a standard of care antibiotic regimen that is based upon the identification and antibiotic susceptibility pattern of the baseline organism. Subjects randomized to the dalbavancin treatment group will receive 2 doses of dalbavancin intravenously (IV) 1 week apart (1500 mg on Day 1 and Day 8 after randomization, with renal dose adjustment if appropriate). Subjects randomized to the standard of care antibiotic therapy treatment group will receive an antibiotic regimen considered to be standard of care based on the methicillin susceptibility pattern of the pathogen isolated at baseline for a duration of 4 to 6 weeks and up to 8 weeks for patients with vertebral osteomyelitis/discitis. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at Day 70 of dalbavancin to that of standard of care antibiotic therapy used to consolidate therapy for the treatment of subjects with complicated S. aureus bacteremia in the intent-to-treat population (ITT).
Study identification
- NCT ID
- NCT04775953
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- Cefazolin Drug
- Dalbavancin Drug
- Daptomycin Drug
- Nafcillin Drug
- Oxacillin Drug
- Vancomycin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 21, 2021
- Primary completion
- Oct 5, 2023
- Completion
- Nov 30, 2023
- Last update posted
- Dec 9, 2024
2021 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama | 35233 | — |
| University of California Davis Medical Center - Internal Medicine - Infectious Disease | Sacramento | California | 95817-1460 | — |
| Harbor UCLA Medical Center - Medicine - Infectious Diseases | Torrance | California | 90502-2006 | — |
| Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine | Gainesville | Florida | 32610 | — |
| University of South Florida Health - Internal Medicine | Tampa | Florida | 22612 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Ochsner Health - Ochsner Medical Center - Department of Infectious Diseases | New Orleans | Louisiana | 70121 | — |
| Henry Ford Health System - Henry Ford Hospital | Detroit | Michigan | 48202-2608 | — |
| Corewell Health - Infectious Disease | Royal Oak | Michigan | 48073-6757 | — |
| University of Nebraska Medical Center - Infectious Diseases | Omaha | Nebraska | 68198-5400 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| New York Presbyterian Hospital - Weill Cornell Medical Center - Infectious Diseases | New York | New York | 10065-4870 | — |
| SUNY Upstate Medical University - Infectious Disease Division | Syracuse | New York | 13210 | — |
| Atrium Health ID Consultants & Infusion Care Specialists | Charlotte | North Carolina | 28209 | — |
| Duke University Hospital - Infectious Diseases | Durham | North Carolina | 27710 | — |
| East Carolina University - Infectious Diseases and Tropical/Travel Medicine Clinic | Greenville | North Carolina | 27834-9997 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Oregon Health and Science University - Adult Infectious Diseases Clinic | Portland | Oregon | 97239-3098 | — |
| University of Pittsburgh - Medicine - Infectious Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| Prisma Health - Greenville Health System - Infectious Disease | Greenville | South Carolina | 29605 | — |
| The University of Texas - MD Anderson Cancer Center - Infectious Diseases | Houston | Texas | 77030-4000 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04775953, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04775953 live on ClinicalTrials.gov.