Early oral antibiotics in Staphylocopccus aureus bloodstream infectio

Conditions: ow risk Staphylococcus aureus bloodstream infection
MedDRA version: 18.0Level: LLTClassification code 10041943Term: Staphylococcus aureus septicaemiaSystem Organ Class: 100000004862
MedDRA version: 18.0Level: LLTClassification code 10054638Term: Staphylococcus aureus septicemiaSystem Organ Class: 100000004862
Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

Registration Number: EUCTR2013-000577-77-NL

Lead Sponsor: niversity of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 430

Inclusion Criteria

- Blood culture positive for S. aureus not considered to represent contamination
- 5-7 days of adequate intravenous antimicrobial therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

- Polymicrobial bloodstream infection
- Signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, prolonged bacteremia)
- Presence of a non-removable foreign body
- Severe comorbidity

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that in patients with low-risk S. aureus bloodstream infection (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);Secondary Objective: The secondary objective is to measure the potential benefit for the patient (length of hospital stay, complications of i.v. therapy).;Primary end point(s): SAB-related complications (relapsing SAB, deep-seated infection with S. aureus, or attributable mortality);Timepoint(s) of evaluation of this end point: 90 days after the first positiv blood culture with S. aureus

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Length of hospital stay<br>- 14, 30, and 90-day survival<br>- Complications of intravenous therapy<br>;Timepoint(s) of evaluation of this end point: 90 days after the first positiv blood culture with S. aureus