Early oral antibiotics in Staphylocopccus aureus bloodstream infectio

Phase 1

• Conditions: ow risk Staphylococcus aureus bloodstream infection; MedDRA version: 19.0Level: LLTClassification code 10041943Term: Staphylococcus aureus septicaemiaSystem Organ Class: 100000004862; MedDRA version: 19.0Level: LLTClassification code 10054638Term: Staphylococcus aureus septicemiaSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2013-000577-77-DE
• Lead Sponsor: niversity of Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-27
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

- Age at least 18 years
- Not legally incapacitated
- Written informed consent from the trial subject has been obtained
- Blood culture positive for S. aureus
- At least one negative follow-up blood culture obtained within 24-96 hours after the start of adequate therapy
- Five to seven full days of appropriate i.v. antimicrobial therapy administered prior to randomization.

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
- Recent history of prior S. aureus bloodstream infection
- In vitro resistance of S. aureus to all oral or all i.v. study drugs
- Contraindications in reference documents for all oral or all i.v. study drugs
- Signs and symptoms of complicated SAB as judged by an ID physician, such as deep-seated focus,septic shock, prolonged bacteremia, fever on two separate days within 48h before randomization
- Presence of a prosthetic heart valve, deep seated vascular graft with foreign material, ventriculo-atrial shunt
- Presence of prosthetic joint
- Presence of a pacemaker or an automated implantable cardioverter defibrillator device
- Failure to remove (within 4 days) any intravascular catheter, which is present when first positive blood culture was drawn
- Severe liver disease
- End-stage renal disease
- Severe immunodeficiency (e.g. primary immunodeficiency disorders, neutropenia,uncontrolled disease in HIV positive patients, high-dose steroid therapy, hematopoietic stem cell transplantation within 6 months, solid organ transplant, treatment with biologicals)
- life expectancy < 3 months
- Inability to take oral drugs
- Injection drug user
- Expected low compliance with drug regimen
- Participation in other interventional trials
- Pregnant women and nursing mothers
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- 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
- Persons held in an institution by legal or official order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified