Staphylococcus Aureus Bacteremia Antibiotic Treatment Options
NCT01792804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215
Last updated 2020-05-27
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 \[1\]. 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.
Conditions
- Staphylococcus Aureus Infection
Interventions
- DRUG
-
study drug 1
- DRUG
-
Clindamycin
study drug 2
- DRUG
-
Linezolid
study drug 3
- DRUG
-
Flucloxacillin
study drug 4
- DRUG
-
Cloxacillin
study drug 5
- DRUG
-
study drug 6
- DRUG
-
Daptomycin
study drug 7
- DRUG
-
Cefazolin
study drug 8
Sponsors & Collaborators
-
German Research Foundation
collaborator OTHER -
Heinrich-Heine University, Duesseldorf
lead OTHER
Principal Investigators
-
Achim J Kaasch, MD · Heinrich-Heine University, Duesseldorf
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2020-03-26
- Completion
- 2020-03-26
Countries
- France
- Germany
- Netherlands
- Spain
- United Kingdom
Study Locations
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