Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Infective endocarditis (IE) is a serious infection with a significant burden for patients and
hospitals (in France, median length of hospital stay = 43 days), partly due to the long
duration of intravenous (IV) antibacterial treatment recommended by international guidelines,
between 4 and 6 weeks in most situations.
A recent survey of practices regarding the management of IE in France showed that a switch
from IV to oral antibiotics is feasible, when patients with left-sided
Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment,
with or without valvular surgery.
These practices have not been associated with unfavourable outcome, while significantly
reducing the duration and cost of hospitalization, the risk of nosocomial infection, and
patients' discomfort.
There has been no randomized controlled trial (RCT) in the field of IE over the last 20
years; current guidelines are mostly based on expert advice, in vitro studies, animal
experiments, or clinical studies performed before the 90's.
The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in
the field of IE.
Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such
as amoxicillin allow a high level of efficacy in the treatment of IE when orally
administrated after an IV period of induction.
It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this
strategy for streptococci, and enterococci IE with a benefit regarding costs.
The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch
strategy, making it a comparative effectiveness trial that should be able to feed the next
revision of IE international guidelines and to change practices in IE management.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Tours
Treatments:
Amoxicillin Ceftriaxone Gentamicins Netilmicin Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins Polystyrene sulfonic acid Vancomycin