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ID
Source
Brief title
Health condition
Staphylococcus aureus bacteremia
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite of all-cause mortality or bacteriologically confirmed disease relapse.
Secondary outcome
Secondary outcomes will include antibiotic-related toxicity, length of hospital admission, perceived quality of life and societal costs.
Background summary
Rationale: Unnecessary long-term exposure to antibiotics should be avoided since it increases the risk of adverse events such as renal and hepatic toxicity, health-care-related infections and antibiotic resistance. Previously it has been shown that antibiotic treatment for many bacterial infections such as pneumonia and blood-stream infections can safely and significantly be shortened. Staphylococcus aureus bacteremia (SAB) is one of the most common serious bacterial infections worldwide. Complicated SAB is typically treated with 6 weeks of antibiotics, but there are no randomized studies to guide this duration. International guidelines are not conclusive and recommend 4 to 6 weeks of treatment. The objective of this trial is to determine if 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment. We will conduct a multi-center, non-inferiority, randomized controlled open trial comparing 4 versus 6 weeks of intravenous antibiotic therapy in patients with complicated SAB.
Study objective
We hypothesize that 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
Study design
Follow-up period is from 28 days after initiation of therapy to 6 months thereafter.
Intervention
Participants will be randomized to stop antibiotic treatment after either 4 weeks (28 days) or 6 weeks (42 days).
Inclusion criteria
Adults with methicillin-sensitive complicated SAB with satisfactory clinical response to initial treatment will be eligible for inclusion.
Exclusion criteria
Patients with infected prosthetic material or pregnant/lactating will be excluded.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8347 |
| Other | METC VUmc : 848018006 |