Universität zu Köln

Kaasch, Achim J., Faetkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiss, Verena, Jung, Norma, Rieg, Siegbert ORCID: 0000-0001-7493-7080, Kern, Winfried V. and Seifert, Harald (2015). Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Trials, 16. LONDON: BMC. ISSN 1745-6215

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Abstract

Background: Current 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/Design: The 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. Discussion: The 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kaasch, Achim J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Prinz-Langenohl, Reinhild UNSPECIFIED UNSPECIFIED UNSPECIFIED Paulus, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Weiss, Verena UNSPECIFIED UNSPECIFIED UNSPECIFIED Jung, Norma UNSPECIFIED UNSPECIFIED UNSPECIFIED Rieg, Siegbert UNSPECIFIED orcid.org/0000-0001-7493-7080 UNSPECIFIED Kern, Winfried V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seifert, Harald UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-389966
DOI:	10.1186/s13063-015-0973-x
Journal or Publication Title:	Trials
Volume:	16
Date:	2015
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLINICAL-PRACTICE GUIDELINES; PROSPECTIVE MULTICENTER; DISEASES SOCIETY; BACTEREMIA; ADULTS; MANAGEMENT; DIAGNOSIS; CRITERIA Multiple languages Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/38996