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evident
Original paper
2019NEJMInfectious Disease

POET

Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis

RCTEndocarditis

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Overview

In stable left-sided endocarditis, switching to oral antibiotics after at least 10 days of IV therapy was noninferior to staying on IV treatment.

Clinical takeaway

In selected adults who are already stable on IV antibiotics for left-sided endocarditis caused by streptococcus, E. faecalis, S. aureus, or coagulase-negative staphylococci, a switch to oral therapy after at least 10 days of IV treatment was noninferior to continued IV therapy. This is not a superiority result.

Key result

The primary composite occurred in 12.1% with continued IV therapy versus 9.0% after an oral switch (between-group difference 3.1 percentage points; 95% CI -3.4 to 9.6; P=0.40), which met noninferiority criteria.

Practice impact

After at least 10 days of IV therapy, consider an oral step-down in stable left-sided endocarditis due to the organisms studied; this is noninferiority, not proof that oral therapy is better.

Evidence

Study design

Randomized, noninferiority, multicenter trial of a switch to oral antibiotics versus continued intravenous antibiotics.

Enrollment

400

Follow-up

From randomization until 6 months after antibiotic treatment was completed.

Geography

Not listed

Clinical question

In stable left-sided endocarditis, is changing from intravenous to oral antibiotics noninferior to continued intravenous treatment?

Population

  • 400 adults in stable condition who had endocarditis on the left side of the heart caused by streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci and who were being treated with intravenous antibiotics.
  • In all patients, antibiotic treatment was administered intravenously for at least 10 days.

Intervention

Switch to oral antibiotic treatment (201 patients). If feasible, patients in the orally treated group were discharged to outpatient treatment.

Comparator

Continue intravenous antibiotic treatment (199 patients).

Primary outcome

Composite of all-cause mortality, unplanned cardiac surgery, embolic events, or relapse of bacteremia with the primary pathogen, from randomization until 6 months after antibiotic treatment was completed.

Changing to oral antibiotics was noninferior to continued intravenous treatment. The 95% CI for the 3.1-percentage-point difference includes no effect, so this is not a superiority finding (P=0.40).

Between-group difference (percentage points) / 3.1 / 95% CI -3.4 to 9.6 / p=0.40

Key results

  • After randomization, antibiotic treatment was completed after a median of 19 days (IQR 14-25) in the intravenously treated group and 17 days (IQR 14-25) in the orally treated group (P=0.48).
  • The primary composite outcome occurred in 24 patients (12.1%) in the intravenously treated group and in 18 (9.0%) in the orally treated group; between-group difference 3.1 percentage points (95% CI -3.4 to 9.6; P=0.40), which met noninferiority criteria.

Harms

Not listed.

Clinical Use

Practice impact

  • In stable left-sided endocarditis due to the listed organisms, an oral step-down after at least 10 days of IV therapy is a reasonable alternative to finishing the course intravenously.

Applicability

  • Adults already in stable condition on IV antibiotics for left-sided endocarditis caused by streptococcus, E. faecalis, S. aureus, or coagulase-negative staphylococci.
  • Everyone had received at least 10 days of intravenous antibiotics before the oral switch.

Limitations

  • The abstract does not state the numerical noninferiority margin.
  • Specific oral regimens are not listed.
  • This does not enroll unstable patients, right-sided endocarditis, or other pathogens.

Common misinterpretations

  • Noninferiority is not superiority; the confidence interval includes no difference.
  • This is not a license to start oral therapy on day 1 or to treat unstable endocarditis orally.

Related evidence

OVIVA - Similar Question

Citation

Iversen K, Ihlemann N, Gill SU, et al. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019;380(5):415-424. doi:10.1056/NEJMoa1808312

In patients with endocarditis on the left side of the heart who were in stable condition, changing to oral antibiotic treatment was noninferior to continued intravenous antibiotic treatment.