Cardio-oncology & otherRandomised controlled trial
Response-Tailored or Standard-Duration Antibiotic Treatment for Infective Endocarditis
- Randomised controlled trial
- international
- open-label
- non-inferiority (primary safety end point)
Authors' conclusion
Among patients with infective endocarditis on the left side of the heart, the use of a response-tailored antibiotic strategy resulted in a longer time alive without antibiotic therapy than standard-duration therapy and met the criterion for noninferiority with respect to safety but was associated with a higher incidence of relapse of bacteremia or infective endocarditis.
Study context
- Population
- Adults in stable condition with left-sided infective endocarditis caused by Staphylococcus aureus, Enterococcus faecalis or streptococcus species
- Participants
- 508 adults
- Comparison
- Response-tailored vs standard-duration antibiotic therapy
- Primary endpoint
- Days alive without antibiotic treatment for infective endocarditis or bacteremia (superiority); primary safety: death from any cause, unplanned cardiac surgery or symptomatic embolic events (noninferiority, margin 7.5 percentage points)
- Follow-up
- 6 months after randomization
Primary result
Days alive without antibiotic treatment · 6 months
Hodges-Lehmann estimated difference
13 days
95% CI 12–13
P < 0.001
By group
As reported in the abstract
Secondary outcomes
Relapse of bacteremia or infective endocarditis (key secondary)
P = 0.04
Safety
| Outcome | Tailored therapy | Standard therapy | absolute between-group difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Primary safety end point: death from any cause, unplanned cardiac surgery or symptomatic embolic events · 6 months · noninferiority | 8.2% | 10.7% | −2.4 (−7.7 to 2.7) | P < 0.001 | |
| −10−505Difference, percentage points (linear scale) |
- Primary safety end point: death from any cause, unplanned cardiac surgery or symptomatic embolic events: noninferiority margin 7.5 percentage points; noninferiority met
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Summarised from the published abstract; every number is checked against it