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Antibiotic

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

Phase 3
Waitlist Available
Led By Louis BERNARD, MD,PHD
Research Sponsored by University Hospital, Tours
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks after randomisation
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Infective Endocarditis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks after randomisation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks after randomisation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment failure
Secondary study objectives
Biological collection for further analysis on endocarditis
Budget impact analysis (BIA)
Catheter related adverse events
+15 more

Side effects data

From 2023 Phase 4 trial • 23 Patients • NCT05010304
9%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pediatric Patients With a History of Penicillin Allergy

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral switch treatmentExperimental Treatment1 Intervention
Oral switch to amoxicillin
Group II: Conventional IV treatment according to european guidelinesActive Control1 Intervention
Conventional IV treatment of streptococci/enterococci IE (European guidelines 2015)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
FDA approved

Find a Location

Who is running the clinical trial?

University Hospital, ToursLead Sponsor
323 Previous Clinical Trials
5,226,293 Total Patients Enrolled
Louis BERNARD, MD,PHDPrincipal InvestigatorCHRU TOURS
1 Previous Clinical Trials
324 Total Patients Enrolled
~33 spots leftby Dec 2025