Abstract
BackgroundCurrent guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy. This serves to avoid SAB-related complications such as relapses, local extension and distant metastatic foci. However, in certain clinical scenarios, the incidence of SAB-related complications is low. Patients with a low-risk for complications may thus benefit from an early switch to oral medication through earlier discharge and fewer complications of intravenous therapy.The major objective for the SABATO trial is to demonstrate that in patients with low-risk SAB a switch from intravenous to oral antimicrobial therapy (oral switch therapy, OST) is non-inferior to a conventional course of intravenous therapy (intravenous standard therapy, IST).Methods/DesignThe trial is designed as randomized, parallel-group, observer-blinded, clinical non-inferiority trial. The primary endpoint is the occurrence of a SAB-related complication (relapsing SAB, deep-seated infection, and attributable mortality) within 90 days. Secondary endpoints are the length of hospital stay; 14-day, 30-day, and 90-day mortality; and complications of intravenous therapy. Patients with SAB who have received 5 to 7 full days of adequate intravenous antimicrobial therapy are eligible. Main exclusion criteria are polymicrobial bloodstream infection, signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, and prolonged bacteremia), the presence of a non-removable foreign body, and severe comorbidity. Patients will receive either OST or IST with a protocol-approved antimicrobial and are followed up for 90 days. Four hundred thirty patients will be randomized 1:1 in two study arms. Efficacy regarding incidence of SAB-related complications is tested sequentially with a non-inferiority margin of 10 and 5 percentage points.DiscussionThe SABATO trial assesses whether early oral switch therapy is safe and effective for patients with low-risk SAB. Regardless of the result, this pragmatic trial will strongly influence the standard of care in SAB.Trial registrationClinicalTrials.gov NCT01792804 registered 13 February 2013; German Clinical trials register DRKS00004741 registered 4 October 2013, EudraCT 2013-000577-77. First patient randomized on 20 December 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0973-x) contains supplementary material, which is available to authorized users.
Highlights
Current guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy
The SABATO trial assesses whether early oral switch therapy is safe and effective for patients with low-risk SAB
This study suggests that orally administered antimicrobials may be as effective as intravenous therapy
Summary
The SABATO trial will assess whether an early switch to oral medication is as safe and effective as intravenous standard therapy. We considered “microbiological success,” demonstrated by a negative blood culture as a test of cure at EOT Since patients in this trial have already been treated for 7 days with antimicrobials before randomization, almost all blood cultures obtained at EOT are expected to yield a negative result. Early oral switch therapy is often applied in other infections, it has never been assessed in SAB This trial will close gaps in our understanding and regardless of the result the trial will influence medical practice. HS identified the research question, participated in the design of the study and coordinated the study.
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