Evidence map›Paper›PMID 35578360›Full record

ArticleTrials2022

Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial.

Nicholas A Turner, Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, Tatiana Beresnev, Todd Riccobene, Rinal Patel and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04775953 (Dalbavancin as an Option for Treatment of S. Aureus Bacteremia), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
5.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04775953 phase2completednot on this map

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

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2021 to 2023Enrolled200ConditionsStaphylococcal BacteraemiaArmsCefazolin, Dalbavancin, Daptomycin, Nafcillin, Oxacillin
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 51 citations in OpenAlex.

  1. Trial
  2. Economic Outcomes of Dalbavancin versus Standard Therapy in Staphylococcus aureus Bacteremia in the DOTS Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  3. Article
  4. Article
  5. Adjunctive Fosfomycin for the Treatment of Staphylococcus aureus Bacteremia: A Pooled Post Hoc Analysis of Individual Participant Data From 2 Randomized Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  6. Case Series: Use of Dalbavancin for Invasive Gram-Positive Infection in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
  7. Article
  8. Article
  9. Review
  10. Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Interagency Collaboration for Patient-Centered Antibacterial Drug Development.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 1 country.

Nicholas A TurnerDivision of Infectious Diseases, Duke University School of Medicine, Durham, NC, USA.
Smitha ZaharoffDuke Clinical Research Institute, Durham, NC, USA.
Heather KingPopulation Health Sciences and Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA.
Scott EvansThe Biostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Toshimitsu HamasakiThe Biostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Thomas LodiseDepartment of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.
Varduhi GhazaryanDivision of Microbiology and Infectious Diseases (DMID), National Institutes of Health (NIH), Bethesda, MD, USA.
Tatiana BeresnevDivision of Microbiology and Infectious Diseases (DMID), National Institutes of Health (NIH), Bethesda, MD, USA.
Todd RiccobeneAbbVie, Madison, NJ, USA.
Rinal PatelAbbVie, Madison, NJ, USA.
Sarah B DoernbergDivision of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Urania RappoBiomX, Inc, Branford, CT, USA.
Vance G FowlerDivision of Infectious Diseases, Duke University School of Medicine, Durham, NC, USA.
Thomas L HollandDivision of Infectious Diseases, Duke University School of Medicine, Durham, NC, USA. thomas.holland@duke.edu.ORCID http://orcid.org/0000-0001-7745-9010
Antibacterial Resistance Leadership Group (ARLG)
Duke University · USAbbVie (United States) · USMilken Institute · USNational Institutes of Health · USAlbany College of Pharmacy and Health Sciences · USClinical Research Institute · USUniversity of California, San Francisco · US

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
HSRD VA CIN 13-410National Institute of Allergy and Infectious Diseases UM1AI104681NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

backgroundStaphylococcus aureus bacteremia is a life-threatening infection and leading cause of infective endocarditis, with mortality rates of 15-50%. Treatment typically requires prolonged administration of parenteral therapy, itself associated with high costs and potential catheter-associated complications. Dalbavancin is a lipoglycopeptide with potent activity against Staphylococcus and a long half-life, making it an appealing potential therapy for S. aureus bacteremia without the need for durable central venous access.

methodsDOTS is a phase 2b, multicenter, randomized, assessor-blinded, superiority, active-controlled, parallel-group trial. The trial will enroll 200 adults diagnosed with complicated S. aureus bacteremia, including definite or possible right-sided infective endocarditis, who have been treated with effective antibiotic therapy for at least 72 h (maximum 10 days) and with subsequent clearance of bacteremia prior to randomization to study treatment. Subjects will be randomized 1:1 to complete their antibiotic treatment course with either two doses of dalbavancin on days 1 and 8, or with a total of 4-8 weeks of standard intravenous antibiotic therapy. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at day 70 for patients randomized to dalbavancin versus standard of care. Key secondary endpoints include quality of life outcomes and pharmacokinetic analyses of dalbavancin. DISCUSSION: The DOTS trial will establish whether dalbavancin is superior to standard parenteral antibiotic therapy for the completion of treatment of complicated S. aureus bacteremia.

trial registrationUS National Institutes of Health ClinicalTrials.gov NCT04775953 . Registered on 1 March 2021.

Indexed as

BacteremiaEndocarditisMethicillin-Resistant Staphylococcus aureusStaphylococcal InfectionsAdultAnti-Bacterial AgentsEquivalence Trials as TopicHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicStaphylococcus aureusTeicoplaninTreatment OutcomeAnti-Bacterial AgentsdalbavancinTeicoplaninBacteremiaDalbavancinRandomized controlled trialRight-sided endocarditisStaphylococcus aureus

Identifiers

PMID35578360
PMCPMC9109297
OpenAlexW4280561604

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.