Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT02701595
Eligibility Criteria:
Inclusion Criteria:
* Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve
* due to one isolate of Streptococcus/Enterococcus sp. susceptible to amoxicillin (MCI ≤ 0.5 mg/l)
* 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 \< 38°C) 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/m² or \> 40 kg/m²
* glomerular filtration rate \< 30 ml/min/1,73m²
* 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
* for 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. amoxicillin) - including anticipated non-manageable drug interactions, and allergy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02701595
Study Brief:
Protocol Section:
NCT02701595