Last updated on September 2018

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bacterial Endocarditis | Endocarditis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve
  • due to one isolate of Staphylococcus sp. (S. aureus or coagulase negative staphylococci, CNS) susceptible to levofloxacin and rifampicin
  • in an adult 18 year old
  • appropriate parenteral antibiotics treatment received for at least 10 days
  • in case of valvular surgery, appropriate parenteral antibiotics treatment received for at least 10 days after valvular surgery
  • planned duration of antibiotics will extend for at least 14 days at the time of randomisation i.e. a potential switch to oral treatment between Day 10 and Day 28 thus ensuring to have at least 14 days of oral therapy remaining in the experimental group
  • apyrexia (temperature < 38C) at each time point during the last 48 hours (at least two measures/day) at the time of randomisation
  • blood cultures have been sterile for at least 5 days at the time of randomisation
  • informed, written consent obtained from patient
  • subject covered by or having the rights to French social security

Exclusion Criteria:

  • body mass index <15 kg/m or > 40 kg/m
  • glomerular filtration rate < 50 ml/min/1,73m
  • patient unable or unwilling to take oral treatment (digestive intolerance, significant malabsorption) at the time of randomisation
  • expected difficulties regarding compliance with oral antibiotic treatment or follow-up (e.g. severe cognitive impairment, severe psychiatric disease...)
  • patient without entourage to support and watch him at discharge
  • valvular surgery planned within the next 6 months
  • patients with cardiac devices (pace-maker, implantable cardiac defibrillator) and suspected device-related IE (vegetation on the leads) if removal of the device was not performed
  • breast feeding or pregnant women, or women on childbearing age without effective contraception
  • expected duration of follow-up < 7 months at the time of randomisation (e.g. expected life expectancy < 7 months, patient living abroad...)
  • past medical history of IE in the last 3 months
  • other infection requiring parenteral antibiotic therapy
  • taking of an estrogen-progesterone treatment interacting with rifampicin
  • patient with contra-indication to oral antibiotics administered in the experimental arm (i.e. fluoroquinolones or rifampicin ) - including anticipated non-manageable drug interactions with rifampicin, and allergy.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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