ClinicalTrials.gg
Enrolling by invitationNCT07148960SABEDTIOUpdated Sep 17, 2026

Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

A Phase 4 interventional study of Early Dual IV Antibiotic Therapy - MRSA and Early Dual IV Antibiotic Therapy - MSSA in Staphylococcus Aureus Bacteremia, sponsored by West Virginia University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by West Virginia University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this open-label, pragmatic, randomized controlled clinical trial is to learn if patients with Staphylococcus aureus bacteremia (SAB) given the intervention of early dual intravenous (IV) antibiotic therapy will decrease duration of bacteremia (\< 6 days) and improve outcomes compared to single IV antibiotic therapy.

The main questions this study aims to answer are:

  • To decrease SAB duration and improve outcomes by using early dual vs. single agent IV antibiotic therapy
  • To accelerate practice transformation of earlier IV to oral (PO) antibiotic transition by switching to PO antibiotic therapy once blood cultures are negative at 72 hours

Participants will be asked to agree to be randomized (like flipping a coin) to receive two or one IV antibiotic(s). Once the infection has cleared, the treatment will be changed to PO antibiotics. As part of usual care, participants will have weekly lab tests for monitoring while on antibiotics, receive a telephone call to see how the participants are doing, and follow up in person or by telephone or video in Infectious Diseases (ID) Clinic. Participant participation will last 12 weeks after the participant is discharged from the hospital.

02

Conditions studied

  • Staphylococcus Aureus Bacteremia

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Keywords

  • MRSA
  • MSSA
03

In context

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's planned enrollment of 300 is above the median of 156 across 156 interventional studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient is hospitalized at J.W. Ruby Memorial Hospital, Berkeley Medical Center, Camden Clark Medical Center, Princeton Community Hospital, United Hospital Center, or Wheeling Hospital
  • The patient has been identified to have Staphylococcus aureus bacteremia
  • The patient is able to participate in lab monitoring and in-person or telemedicine ID Clinic follow-up

Exclusion criteria

Exclusion Criteria:

  • The patient or an appointed medical decision maker is unable to give
  • The patient is a prisoner, pregnant, and/or mentally handicapped
  • The patient is determined unsafe for enrollment at the primary team's discretion
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Early Dual IV Antibiotic Therapy

    Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given: * MRSA - daptomycin plus ceftaroline; * MSSA - cefazolin plus ertapenem; * MRSA or MSSA - rifampin PO may be added for patients with prosthetic material

    Drug: Early Dual IV Antibiotic Therapy - MRSA · Drug: Early Dual IV Antibiotic Therapy - MSSA

  • Active comparator
    Single Agent IV Antibiotic Therapy

    Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given: * MRSA - daptomycin, vancomycin, or ceftaroline; * MSSA - cefazolin, oxacillin, or nafcillin; * MRSA or MSSA - rifampin PO may be added for patients with prosthetic material

    Drug: Single Agent IV Antibiotic Therapy - MRSA · Drug: Single Agent IV Antibiotic Therapy - MSSA

Interventions

  • Participant given IV daptomycin plus ceftaroline dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.

    Also known as: daptomycin, ceftaroline, rifampin

  • Participant given IV cefazolin plus ertapenem dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.

    Also known as: cefazolin, ertapenem, rifampin

  • Participant given one of the following IV therapies: daptomycin, vancomycin, or ceftaroline. Oral rifampin may be added for participants with prosthetic material.

    Also known as: daptomycin, vancomycin, ceftaroline, rifampin

  • Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin. Oral rifampin may be added for participants with prosthetic material.

    Also known as: cefazolin, oxacillin, nafcillin, rifampin

06

What researchers measure

Primary outcomes

  1. Percentage of participants with prolonged bacteremia (≥ 6 days)

    Percentage of participants with prolonged bacteremia (≥ 6 days) up to 12 weeks post hospital discharge.

    Time frame: Up to 12 weeks post hospital discharge

  2. Seeding of a New Site - Incidence

    Incidence of new infection of heart valve, joint, or spine up to 12 weeks post hospital discharge.

    Time frame: Up to 12 weeks post hospital discharge

  3. All-Cause Mortality

    Number of participants who died from any cause up to 12 weeks post hospital discharge.

    Time frame: Up to 12 weeks post hospital discharge

Secondary outcomes

  1. Number of patients with cure/control

    Number of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters.

    Time frame: Up to 12 weeks post hospital discharge

  2. Time to Positivity (TTP)

    Time in hours from first set of blood culture bottle on laboratory instrument to positive culture bottle off laboratory instrument (TTP1).

    Time frame: Up to 14 days post hospital admission

  3. Sequential Time to Positivity (STTP)

    Ratio of the Time to Positivity of the second set of blood cultures divided by the first set of blood cultures (TTP2/TTP1).

    Time frame: Up to 14 days post hospital admission

  4. Length of Hospital Stay

    Duration in days from hospital admission to hospital discharge.

    Time frame: Up to 12 weeks post hospital discharge

  5. Overall Hospital Readmission

    Number of participants readmitted for any reason up to 12 weeks after discharge from the hospital.

    Time frame: Up to 12 weeks post hospital discharge

  6. Rate of Relapsed Bacteremia

    Recurrence of bacteremia with the same organism one week after initial clearance.

    Time frame: Up to 12 weeks post hospital discharge

  7. Time to First Negative Blood Culture

    Time from hospital admission to the first documented negative blood culture.

    Time frame: Up to 14 days post hospital admission

  8. Incidence of Antibiotic-Associated Side Effects and Toxicity

    Occurrence of adverse events related to antibiotic therapy, including Clostridioides difficile infection, as assessed by clinical evaluation and laboratory testing.

    Time frame: Up to 12 weeks post hospital discharge

07

Study locations

1 site
08

References and documents

Publications

  • Kim M, Ranganath N, Chesdachai S, Stevens RW, Sohail MR, Abu Saleh OM. Which trial do we need? Combination therapy with daptomycin plus ceftaroline versus standard-of-care monotherapy in the treatment of methicillin-resistant Staphylococcus aureus bacteraemia. Clin Microbiol Infect. 2025 Jan;31(1):18-21. doi: 10.1016/j.cmi.2024.08.011. Epub 2024 Sep 7. No abstract available. PubMed 39182576 ↗
  • Juskowich JJ, Thompson JM, Bage SD, Palmateer KM, Guilfoose JA, Lastinger AM, Smith CL, Arcega VA, Stanley JE, Summerfield HM, Fisher-Duda C, Nepal M, Wen S, Sarwari AR. Using the Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Clinical Trial to Influence Institutional Practice Transformation Towards Earlier Transition to Oral Antibiotics. Clin Infect Dis. 2026 Apr 30;82(4):e674-e681. doi: 10.1093/cid/ciaf707. PubMed 41419216 ↗
  • Juskowich JJ, Thompson JM, Guilfoose JG, et al. P-106. Preliminary Results of the Comparing Oral versus Parenteral Antimicrobial Therapy (COPAT) Clinical Trial. Open Forum Infect Dis 2025;12(1):S197-198.
  • Juskowich JJ, Thompson JM, Sarwari AR. 333. How the COVID-19 Pandemic Accelerated Development of our Complex Outpatient Oral Antimicrobial Therapy (COpAT) Program. Open Forum Infect Dis 2023;10(2):S212.
  • Juskowich JJ, Ward A, Spigelmyer AE, et al. 1002. Complex Outpatient Antimicrobial Therapy (COpAT) Program at a Rural Academic Medical Center: Evaluation of First 100 Patients. Open Forum Infect Dis 2022;9(2):S418-S419.
  • Kaasch AJ, Lopez-Cortes LE, Rodriguez-Bano J, Cisneros JM, Dolores Navarro M, Fatkenheuer G, Jung N, Rieg S, Lepeule R, Coutte L, Bernard L, Lemaignen A, Kosters K, MacKenzie CR, Soriano A, Hagel S, Fantin B, Lafaurie M, Talarmin JP, Dinh A, Guimard T, Boutoille D, Welte T, Reuter S, Kluytmans J, Martin ML, Forestier E, Stocker H, Vitrat V, Tattevin P, Rommerskirchen A, Noret M, Adams A, Kern WV, Hellmich M, Seifert H; SABATO study group. Efficacy and safety of an early oral switch in low-risk Staphylococcus aureus bloodstream infection (SABATO): an international, open-label, parallel-group, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2024 May;24(5):523-534. doi: 10.1016/S1473-3099(23)00756-9. Epub 2024 Jan 17. PubMed 38244557 ↗
  • Kaasch AJ, Barlow G, Edgeworth JD, Fowler VG Jr, Hellmich M, Hopkins S, Kern WV, Llewelyn MJ, Rieg S, Rodriguez-Bano J, Scarborough M, Seifert H, Soriano A, Tilley R, Torok ME, Weiss V, Wilson AP, Thwaites GE; ISAC, INSTINCT, SABG, UKCIRG, and Colleagues. Staphylococcus aureus bloodstream infection: a pooled analysis of five prospective, observational studies. J Infect. 2014 Mar;68(3):242-51. doi: 10.1016/j.jinf.2013.10.015. Epub 2013 Nov 16. PubMed 24247070 ↗
  • Li HK, Rombach I, Zambellas R, Walker AS, McNally MA, Atkins BL, Lipsky BA, Hughes HC, Bose D, Kumin M, Scarborough C, Matthews PC, Brent AJ, Lomas J, Gundle R, Rogers M, Taylor A, Angus B, Byren I, Berendt AR, Warren S, Fitzgerald FE, Mack DJF, Hopkins S, Folb J, Reynolds HE, Moore E, Marshall J, Jenkins N, Moran CE, Woodhouse AF, Stafford S, Seaton RA, Vallance C, Hemsley CJ, Bisnauthsing K, Sandoe JAT, Aggarwal I, Ellis SC, Bunn DJ, Sutherland RK, Barlow G, Cooper C, Geue C, McMeekin N, Briggs AH, Sendi P, Khatamzas E, Wangrangsimakul T, Wong THN, Barrett LK, Alvand A, Old CF, Bostock J, Paul J, Cooke G, Thwaites GE, Bejon P, Scarborough M; OVIVA Trial Collaborators. Oral versus Intravenous Antibiotics for Bone and Joint Infection. N Engl J Med. 2019 Jan 31;380(5):425-436. doi: 10.1056/NEJMoa1710926. PubMed 30699315 ↗
  • Comba IY, Go JR, Vaillant J, O'Horo JC, Stevens RW, Palraj R, Abu Saleh O. Sequential Time to Positivity as a Prognostic Indicator in Staphylococcus aureus Bacteremia. Open Forum Infect Dis. 2024 Mar 21;11(4):ofae173. doi: 10.1093/ofid/ofae173. eCollection 2024 Apr. PubMed 38617074 ↗
  • Cao Y, Guimaraes AO, Peck MC, Mayba O, Ruffin F, Hong K, Carrasco-Triguero M, Fowler VG Jr, Maskarinec SA, Rosenberger CM. Risk stratification biomarkers for Staphylococcus aureus bacteraemia. Clin Transl Immunology. 2020 Feb 13;9(2):e1110. doi: 10.1002/cti2.1110. eCollection 2020. PubMed 32082571 ↗
  • Bai AD, Lo CKL, Komorowski AS, Suresh M, Guo K, Garg A, Tandon P, Senecal J, Del Corpo O, Stefanova I, Fogarty C, Butler-Laporte G, McDonald EG, Cheng MP, Morris AM, Loeb M, Lee TC. Staphylococcus aureus bacteraemia mortality: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 Aug;28(8):1076-1084. doi: 10.1016/j.cmi.2022.03.015. Epub 2022 Mar 23. PubMed 35339678 ↗
  • Honda H, Krauss MJ, Jones JC, Olsen MA, Warren DK. The value of infectious diseases consultation in Staphylococcus aureus bacteremia. Am J Med. 2010 Jul;123(7):631-7. doi: 10.1016/j.amjmed.2010.01.015. Epub 2010 May 20. PubMed 20493464 ↗
  • Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28. PubMed 30152252 ↗
  • Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4. PubMed 21208910 ↗
  • Liu C, Strnad L, Beekmann SE, Polgreen PM, Chambers HF. Clinical Practice Variation Among Adult Infectious Disease Physicians in the Management of Staphylococcus aureus Bacteremia. Clin Infect Dis. 2019 Jul 18;69(3):530-533. doi: 10.1093/cid/ciy1144. PubMed 30601989 ↗
  • Minejima E, Mai N, Bui N, Mert M, Mack WJ, She RC, Nieberg P, Spellberg B, Wong-Beringer A. Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):566-573. doi: 10.1093/cid/ciz257. PubMed 30949675 ↗
  • Mourad A, Nwafo N, Skalla L, Holland TL, Jenkins TC. Oral Versus Intravenous Antibiotic Therapy for Staphylococcus aureus Bacteremia or Endocarditis: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials. Clin Infect Dis. 2025 Feb 5;80(1):29-36. doi: 10.1093/cid/ciae476. PubMed 39290168 ↗
  • Pries-Heje MM, Wiingaard C, Ihlemann N, Gill SU, Bruun NE, Elming H, Povlsen JA, Madsen T, Jensen KT, Fursted K, Schultz M, Ostergaard L, Christensen JJ, Christiansen U, Rosenvinge F, Helweg-Larsen J, Fosbol EL, Kober L, Torp-Pedersen C, Tonder N, Moser C, Iversen K, Bundgaard H. Five-Year Outcomes of the Partial Oral Treatment of Endocarditis (POET) Trial. N Engl J Med. 2022 Feb 10;386(6):601-602. doi: 10.1056/NEJMc2114046. No abstract available. PubMed 35139280 ↗
  • Swets MC, Bakk Z, Westgeest AC, Berry K, Cooper G, Sim W, Lee RS, Gan TY, Donlon W, Besu A, Heppenstall E, Tysall L, Dewar S, de Boer M, Fowler VG Jr, Dockrell DH, Thwaites GE, Pujol M, Pallares N, Tebe C, Carratala J, Szubert A, Groeneveld GH, Russell CD. Clinical Subphenotypes of Staphylococcus aureus Bacteremia. Clin Infect Dis. 2024 Nov 22;79(5):1153-1161. doi: 10.1093/cid/ciae338. PubMed 38916975 ↗
  • Percival KM. The Changing Landscape of OPAT to COpAT. Haelio: Infectious Diseases News. May 9, 2023. Accessed May 10, 2023.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07148960
Responsible party
Joy J. Juskowich, MD (Assistant Professor and COpAT Medical Director, West Virginia University) — Principal investigator
First posted
Aug 29, 2025
Start date
Sep 15, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Joy J Juskowich, MD
principal investigator · West Virginia University
Arif R Sawari, MD, MSc, MBA
principal investigator · West Virginia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Daptomycin · Cefazolin

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