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Staphylococcus Aureus InfectionPhase 3SABATONCT01792804

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

A Phase 3 study testing Trimethoprim-Sulfamethoxazole, Clindamycin and Linezolid in people with Staphylococcus Aureus Infection, run by Heinrich-Heine University, Duesseldorf at 40 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade [1]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcus Aureus Infection
What is being tested?
Trimethoprim-Sulfamethoxazole, Clindamycin and Linezolid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
40 sitesin 5 countries
Study dates
Dec 2013to 26 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Age at least 18 years
  • Not legally incapacitated
  • Written informed consent from the trial subject has been obtained
  • Blood culture positive for S. aureus not considered to represent contamination
  • At least one negative follow-up blood culture obtained within 24-96 hours after the start of adequate antimicrobial therapy to rule out persistent bacteremia and Absence of a blood culture positive for S. aureus at the same time or thereafter.
  • Five to seven full days of appropriate i.v. antimicrobial therapy administered prior to randomization documented in the patient Chart. Appropriate therapy has all of the following characteristics:
Show all 10Show fewer
  • Antimicrobial therapy has to be initiated within 72h after the first positive blood culture was drawn.
  • Provided in-vitro susceptibility and adequate dosing (as judged by the PI) preferred agents for pre-randomization antimicrobial therapy are flucloxacillin, cloxacillin, vancomycin and daptomycin. However, the following antimicrobials are allowed:
  • MSSR: penicillinase-resistant penicillins (e.g. flucloxacillin, cloxacillin), β-lactam plus β-lactamase-inhibitors (e.g. ampicillin+sulbactam, piperacillin+tazobactam), cephalosporins (except ceftazidime), carbapenems, clindamycin, fluoroquinolones, trimethoprimsulfamethoxazole, doxycycline, tigecycline, vancomycin, teicoplanin, telavancin, linezolid, daptomycin, ceftaroline, ceftobiprole, and macrolides.
  • MRSA: vancomycin, teicoplanin, telavancin, fluoroquinolones, clindamycin, trimethoprim-sulfamethoxazole, doxycycline, tigecycline, linezolid, daptomycin, macrolides, ceftaroline, and ceftobiprole.

Who cannot join

  • Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained in the time from two days prior to the first positive blood culture with S. aureus until randomization. Common skin contaminants (coagulase-negative staphylococci, diphtheroids, Bacillus spp., and Propionibacterium spp.) detected in one of several blood cultures will not be considered to represent polymicrobial infection
  • Recent history (within 3 months) of prior S. aureus bloodstream infection
  • In vitro resistance of S. aureus to all oral or all i.v. study drugs
  • Contraindications for all oral or all i.v. study drugs
  • Previously planned Treatment with active drug against S. aureus during Intervention Phase (e.g. cotrimoxazol prophylaxis)
  • Signs and symptoms of complicated SAB as judged by an ID physician. Complicated infection is defined as at least one of the following:
Show all 59Show fewer
  • deep-seated focus: e.g. endocarditis, pneumonia, undrained abscess, empyema, and Osteomyelitis
  • septic shock, as defined by the AACP criteria (23), within 4 days before randomization
  • prolonged bacteremia: positive follow-up blood culture more than 72h after the start of adequate antimicrobial therapy
  • body temperature >38 °C on two separate days within 48h before randomization
  • Presence of the following non-removable foreign bodies (if not removed 2 days or more before randomization):
  • prosthetic heart valve
  • deep-seated vascular graft with foreign material (e.g. PTFE or dacron graft). Hemodialysis shunts are not considered deep-seated vascular grafts.
  • ventriculo-atrial shunt
  • Presence of a prosthetic joint (if not removed 2 days or more before randomization). This is not an exclusion criterion, if all of the following conditions are fulfilled:
  • prosthetic joint was implanted at least 6 months prior, and
  • catheter-related infection, skin and soft tissue infection, or surgical wound infection is present (as defined below), and
  • joint infection unlikely (no clinical or imaging signs)
  • Presence of a pacemaker or an automated implantable cardioverter Defibrillator (AICD) device (if not removed 2 days or more before randomization). This is not an exclusion criterion, if all of the following conditions are fulfilled:
  • pacemaker or AICD was implanted at least 6 months prior, and
  • catheter-related infection, skin and soft tissue infection, or surgical wound infection is present (as defined below), and
  • no clinical signs of infective endocarditis, and
  • infective endocarditis unlikely by echocardiography (preferably TEE), and
  • pocket infection unlikely (no clinical or imaging signs)
  • Failure to remove any intravascular catheter which was present when first positive blood culture was drawn within 4 days of the first positive blood culture
  • Severe liver disease. This is not an exclusion criterion, if the following condition is fulfilled:
  • catheter-related infection, skin and soft tissue infection, or surgical wound infection is present
  • End-stage renal disease. This is not an exclusion criterion, if all of the following conditions are fulfilled:
  • catheter-related infection, skin and soft tissue infection, or surgical wound infection is present (as defined below), and
  • no clinical signs of infective endocarditis, and
  • infective endocarditis unlikely by echocardiography (preferably TEE), and
  • in patients with a hemodialysis shunt with a non-removable foreign body (e.g. synthetic PTFE loop): no clinical signs of a shunt infection
  • Severe immunodeficiency
  • primary immunodeficiency disorders
  • neutropenia (<500 neutrophils/μl) at randomization or neutropenia expected during intervention phase due to immunosuppressive treatment
  • uncontrolled disease in HIV-positive patients
  • high-dose steroid therapy (>1 mg/kg prednisone or equivalent doses given for >4 weeks or planned during intervention)
  • immunosuppressive combination therapy with two or more drugs with different mode of action
  • hematopoietic stem cell transplantation within the past 6 months or planned during treatment period
  • solid organ transplant
  • treatment with biologicals within the previous year
  • Life expectancy < 3 months
  • Inability to take oral drugs
  • Injection drug user
  • Expected low compliance with drug regimen
  • Participation in other interventional trials within the previous three months or ongoing
  • Pregnant women and nursing mothers
  • For premenopausal women: Failure to use highly-effective contraceptive methods for 1 month after receiving study drug. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
  • oral hormonal contraception ('pill')
  • dermal hormonal contraception
  • vaginal hormonal contraception (NuvaRing®)
  • contraceptive plaster
  • long-acting injectable contraceptives
  • implants that release progesterone (Implanon®)
  • tubal ligation (female sterilisation)
  • intrauterine devices that release hormones (hormone spiral)
  • double barrier methods
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
  • Persons held in an institution by legal or official order

Trial locations and contacts

40 sites in 5 countries.

40 sites in 5 countries

France15 sites

  • Annecy

    Annecy, 74000

  • Chambéry

    Chambéry, 73000

  • Grenoble

    Grenoble, 38700

  • La Roche-sur-Yon

    La Roche-sur-Yon, 85000

  • Nantes

    Nantes, 44000

  • Orléans

    Orléans, 45100

  • Paris 5

    Paris, 75010

  • Paris 1

    Paris, 92100

  • Paris 3

    Paris, 92110

  • Paris 2

    Paris, 93000

  • Paris 4

    Paris, 94010

  • Quimper

    Quimper, 29107

  • Rennes

    Rennes, 35000

  • St. Etienne

    Saint-Etienne, 42800

  • Tours

    Tours, 37000

Other trials in France

Germany11 sites

  • Berlin

    Berlin, 12157

  • Uniklinik Köln

    Cologne, 50935

  • Düsseldorf

    Düsseldorf, 40225

  • Frankfurt

    Frankfurt am Main, 60590

  • Freiburg

    Freiburg im Breisgau, 79106

  • Hannover

    Hanover, 30625

  • Jena

    Jena, 07743

  • Krefeld

    Krefeld, 47805

  • Leverkusen

    Leverkusen, 51375

  • Lübeck

    Lübeck, 23562

  • Ulm

    Ulm, 89081

Other trials in Germany

Netherlands8 sites

  • VUmc Amsterdam

    Amsterdam, 1081

  • Amsterdam

    Amsterdam, 1105 AZ

  • Breda

    Breda, 4814 CK Breda

  • Groningen

    Groningen, 9700 RB

  • UMC Groningen

    Groningen, 9700

  • Tilburg

    Tilburg, 5022GC

  • Utrecht

    Utrecht, 3584 CX

  • Diakonessenhuis Utrecht

    Utrecht, 5022

Other trials in Netherlands

Spain5 sites

  • Barcelona II

    Barcelona, 08035

  • Barcelona I

    Barcelona, 08036

  • Palma

    Palma de Mallorca, 07010

  • Sevilla II

    Seville, 41071

  • Sevilla

    Seville, 41071

Other trials in Spain

United Kingdom1 site

  • Nottingham

    Nottingham, NG7 24 H

Other trials in United Kingdom

About this study

Official title: Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade [1]. This threat underscores the need to maximize clinical utility of existing antibiotics, through more rational prescription, e.g. optimizing duration of treatment.

Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000 cases occurring annually in Europe [2]. A course of at least 14 days of intravenous antimicrobials is considered standard therapy [3-5] in "uncomplicated" SAB. This relatively long course serves to prevent SAB-related complications (such as endocarditis and vertebral osteomyelitis) that may result from hematogenous dissemination to distant sites. However, there is insufficient evidence that a full course of intravenous antibiotic therapy is always required in patients with a low risk of SAB-related complications.

In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.

Read the detailed description
  1. WHO. WHO Global Strategy for Containment of Antimicrobial Resistance.: World Health Organization, 2001.
  2. Kern WV. Management of Staphylococcus aureus bacteremia and endocarditis: progresses and challenges. Curr Opin Infect Dis 2010;23(4):346-58.
  3. Gemmell CG, Edwards DI, Fraise AP, Gould FK, Ridgway GL, Warren RE. Guidelines for the prophylaxis and treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in the UK. J Antimicrob Chemother 2006;57(4):589-608.
  4. Liu C, Bayer A, Cosgrove SE, et al. 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;52(3):e18-55.
  5. Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis 2009;49(1):1-45.
Being tested
Trimethoprim-Sulfamethoxazole, Clindamycin, Linezolid, Flucloxacillin, Cloxacillin
Keywords
Staphylococcus aureus, Bloodstream infection, Oral switch
Medical subject headings
Staphylococcal Infections, Sepsis

What participants receive

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

  • Trimethoprim-SulfamethoxazoleDrug

    study drug 1

  • ClindamycinDrug

    study drug 2

  • LinezolidDrug

    study drug 3

  • FlucloxacillinDrug

    study drug 4

  • CloxacillinDrug

    study drug 5

  • VancomycinDrug

    study drug 6

  • DaptomycinDrug

    study drug 7

  • CefazolinDrug

    study drug 8

Study groups in NCT01792804
Study groupRoleWhat they receive
Orally administered antibioticExperimentalFirst choice (MRSA and MSSA): trimethoprim-sulfamethoxazole, or Second choice (MSSA): clindamycin, or Second choice (MRSA): linezolid administered for 7-9 days
Receives: Drug: Trimethoprim-Sulfamethoxazole; Drug: Clindamycin; Drug: Linezolid
Intravenously administered antibioticExperimentalFirst choice (MSSA): flucloxacillin [Spain: cloxacillin], or cefazolin or Second choice (MSSA): vancomycin, or First choice (MRSA): vancomycin, or Second choice (MRSA): daptomycin administered for 7-9 days
Receives: Drug: Flucloxacillin; Drug: Cloxacillin; Drug: Vancomycin; Drug: Daptomycin; Drug: Cefazolin

What is being measured

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

  1. SAB-related complications

    1. aureus bloodstream infection-related complications (relapsing SAB, deep-seated infection with S. aureus, or attributable mortality) within 90 days

    Measured: 90 days

Secondary outcomes (3)

  1. Length of hospital stay

    Length of hospital stay

    Measured: 90 days

  2. Survival

    Survival at 14, 30, and 90 days

    Measured: 14, 30, and 90 days

  3. Complications of intravenous therapy

    Complications of intravenous therapy, such as thrombophlebitis.

    Measured: 90 days

Timeline

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

  1. First posted15 Feb 2013 (estimated)
  2. Study startDec 2013
  3. Primary completion26 Mar 2020
  4. Study completion26 Mar 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01792804
Sponsor's protocol ID
Uni-Koeln-1400
Other IDs
2013-000577-77
Acronym
SABATO
Status last verified
May 2020
First submitted
13 Feb 2013
Last updated
27 May 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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, Rommerskirchen A, Hellmich M, Fatkenheuer G, Prinz-Langenohl R, Rieg S, Kern WV, Seifert H; SABATO trial group. Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection. Trials. 2020 Feb 12;21(1):175. doi: 10.1186/s13063-020-4102-0.

    PubMed 32051007

  • Kaasch AJ, Fatkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Weiss V, Jung N, Rieg S, Kern WV, Seifert H; SABATO trial group (with linked authorship to the individuals in the Acknowledgements section). Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Trials. 2015 Oct 9;16:450. doi: 10.1186/s13063-015-0973-x.

    PubMed 26452342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trimethoprim-Sulfamethoxazole, Clindamycin and Linezolid in people with Staphylococcus Aureus Infection, run by Heinrich-Heine University, Duesseldorf at 40 sites in 5 countries.

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 10 inclusion and 59 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France, Germany, Netherlands, Spain, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

SAB-related complications (time frame: 90 days). 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 NCT01792804, which also lists 3 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 27 May 2020.

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