Actively Recruiting
A Randomized Placebo-Controlled Trial of Phage Therapy Plus Antibiotics in Patients With Infective Endocarditis
Led by University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba) · Updated on 2026-03-19
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infective endocarditis (IE) is a serious infection affecting the heart valves or endocardium, often caused by bacteria or fungi, with increasing cases mainly in high-income countries. The disease can be complicated and life-threatening, including risks during hospital treatment and afterward. Antibiotic resistance is a growing challenge in treating IE, prompting the need for new therapies like bacteriophage (phage) therapy, which uses viruses that specifically attack bacteria. This trial evaluates phage therapy combined with standard antibiotics compared to a placebo plus antibiotics in patients with IE. Participants receive either a bacteriophage cocktail targeting common bacteria causing IE or a placebo while continuing standard antibiotic treatment. The treatment is given early in the disease to help control infection and reduce resistance risks, potentially allowing earlier transition to outpatient care. Participants will be monitored for up to 8 weeks, with researchers tracking hospital stay length, embolic events, and survival rates. The study involves clinical evaluations, microbiological tests, and safety monitoring to assess how well the combined treatment controls infection. The trial is randomized and placebo-controlled to compare the effects of phage therapy alongside antibiotics in patients hospitalized with active IE.
CONDITIONS
Brief Title
Bacteriophages in Addition to Antibiotics for the Treatment of Patients With Infective Endocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalisation with active infective endocarditis or active infective endocarditis developed in hospital
- Definite diagnosis of infective endocarditis according to modified Duke 2023 criteria or possible diagnosis managed as infective endocarditis
- Informed consent to participate in the study
You will not qualify if you...
- Inactive (transferred) infective endocarditis
- Non-bacterial thrombotic endocarditis
- Active oncological diseases
- Immunosuppressive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either a bacteriophage complex drug or placebo in addition to standard antibiotic therapy for infective endocarditis.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
University Clinical Hospital named after V.V.Vinogradov (branch) of the Peoples' Friendship University of Russia named after Patrice Lumumba
Moscow, Russia
Actively Recruiting
Research Team
Z
Zhanna Davidovna Kobalava, Head of Internal Disease Unit
E
Elizaveta Olegovna Kotova, MD in cardiology department
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here