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Staphylococcus Aureus BacteremiaPhase 4SABEDTIONCT07148960

Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

A Phase 4 study testing Early Dual IV Antibiotic Therapy - MRSA, Early Dual IV Antibiotic Therapy - MSSA and Single Agent IV Antibiotic Therapy - MRSA in people with Staphylococcus Aureus Bacteremia, run by West Virginia University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcus Aureus Bacteremia
What is being tested?
Early Dual IV Antibiotic Therapy - MRSA, Early Dual IV Antibiotic Therapy - MSSA and Single Agent IV Antibiotic Therapy - MRSA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
15 Sep 2025to Jul 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • The patient or an appointed medical decision maker is unable to give informed consent
  • The patient is a prisoner, pregnant, and/or mentally handicapped
  • The patient is determined unsafe for enrollment at the primary team's discretion

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • West Virginia University

    Morgantown, West Virginia, 26506

Other trials in United States

About this study

Official title: Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? (SABEDTIO) Clinical Trial

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:

Read more
  • 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.

Being tested
Early Dual IV Antibiotic Therapy - MRSA, Early Dual IV Antibiotic Therapy - MSSA, Single Agent IV Antibiotic Therapy - MRSA, Single Agent IV Antibiotic Therapy - MSSA
Keywords
MRSA, MSSA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Dual IV Antibiotic Therapy - MRSADrug

    Also called daptomycin, ceftaroline, rifampin

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

  • Early Dual IV Antibiotic Therapy - MSSADrug

    Also called cefazolin, ertapenem, rifampin

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

  • Single Agent IV Antibiotic Therapy - MRSADrug

    Also called daptomycin, vancomycin, ceftaroline, rifampin

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

  • Single Agent IV Antibiotic Therapy - MSSADrug

    Also called cefazolin, oxacillin, nafcillin, rifampin

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

Study groups in NCT07148960
Study groupRoleWhat they receive
Early Dual IV Antibiotic TherapyExperimentalOnce 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
Receives: Drug: Early Dual IV Antibiotic Therapy - MRSA; Drug: Early Dual IV Antibiotic Therapy - MSSA
Single Agent IV Antibiotic TherapyActive comparatorOnce 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
Receives: Drug: Single Agent IV Antibiotic Therapy - MRSA; Drug: Single Agent IV Antibiotic Therapy - MSSA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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.

    Measured: 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.

    Measured: Up to 12 weeks post hospital discharge

Secondary outcomes (8)

  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.

    Measured: 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).

    Measured: 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).

    Measured: Up to 14 days post hospital admission

  4. Length of Hospital Stay

    Duration in days from hospital admission to hospital discharge.

    Measured: 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.

    Measured: Up to 12 weeks post hospital discharge

  6. Rate of Relapsed Bacteremia

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

    Measured: 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.

    Measured: 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.

    Measured: Up to 12 weeks post hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start15 Sep 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07148960
Sponsor's protocol ID
2507187207
Acronym
SABEDTIO
Status last verified
Sep 2026
First submitted
22 Aug 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Early Dual IV Antibiotic Therapy - MRSA, Early Dual IV Antibiotic Therapy - MSSA and Single Agent IV Antibiotic Therapy - MRSA in people with Staphylococcus Aureus Bacteremia, run by West Virginia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with prolonged bacteremia (≥ 6 days) (time frame: Up to 12 weeks post hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07148960, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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