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

Publication ,  Journal Article
Turner, NA; Zaharoff, S; King, H; Evans, S; Hamasaki, T; Lodise, T; Ghazaryan, V; Beresnev, T; Riccobene, T; Patel, R; Doernberg, SB; Rappo, U ...
Published in: Trials
May 16, 2022

BACKGROUND: Staphylococcus 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. METHODS: DOTS 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 REGISTRATION: US National Institutes of Health ClinicalTrials.gov NCT04775953 . Registered on 1 March 2021.

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Published In

Trials

DOI

EISSN

1745-6215

Publication Date

May 16, 2022

Volume

23

Issue

1

Start / End Page

407

Location

England

Related Subject Headings

  • Treatment Outcome
  • Teicoplanin
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Multicenter Studies as Topic
  • Methicillin-Resistant Staphylococcus aureus
  • Humans
  • General & Internal Medicine
 

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Turner, N. A., Zaharoff, S., King, H., Evans, S., Hamasaki, T., Lodise, T., … Antibacterial Resistance Leadership Group (ARLG), . (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, 23(1), 407. https://doi.org/10.1186/s13063-022-06370-1
Turner, Nicholas A., Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, et al. “Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial.Trials 23, no. 1 (May 16, 2022): 407. https://doi.org/10.1186/s13063-022-06370-1.
Turner, Nicholas A., et al. “Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial.Trials, vol. 23, no. 1, May 2022, p. 407. Pubmed, doi:10.1186/s13063-022-06370-1.
Turner NA, Zaharoff S, King H, Evans S, Hamasaki T, Lodise T, Ghazaryan V, Beresnev T, Riccobene T, Patel R, Doernberg SB, Rappo U, Fowler VG, Holland TL, Antibacterial Resistance Leadership Group (ARLG). Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial. Trials. 2022 May 16;23(1):407.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

Publication Date

May 16, 2022

Volume

23

Issue

1

Start / End Page

407

Location

England

Related Subject Headings

  • Treatment Outcome
  • Teicoplanin
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Multicenter Studies as Topic
  • Methicillin-Resistant Staphylococcus aureus
  • Humans
  • General & Internal Medicine