Bacteriophages in Addition to Antibiotics for the Treatment of Patients With Infective Endocarditis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Endocarditis, Bacterial

In brief

Infective endocarditis (IE) is an endocardial lesion caused by bacterial and/or fungal infection that most commonly affects the heart valves and/or the endocardium around implanted intracardiac devices. In general, IE is classified as a rare disease, but there has been a steady increase in incidence, primarily in high-income countries. The danger of IE lies in the high frequency of complicated course of the disease and the risk of lethal outcomes both at the inpatient stage of treatment 25.0% and in the distant period 30-40%. The annual incidence is from 3 to 10 per 100,000 people. In addition to the difficulties in the diagnosis of IE, the most challenging aspect is the prescription of effective antibiotic therapy, especially in the context of unidentified etiology of IE and the growth of multi-resistant pathogens. Many solutions are used to achieve successful therapy of IE, including the prescription of combined antibiotic therapy, the use of new modern antibacterial drugs, the prescription of therapy taking into account the sensitivity of the pathogen, but the failure of treatment and the number of resistant pathogens are only increasing. Moreover, antibacterial therapy is relevant both in patients on conservative treatment of IE and after cardiac surgery, among whom the risk of nosocomial or healthcare-associated infections is additionally increased. Thus, new ways of modernising IE therapy are needed. Phage therapy is considered one of the promising strategies \[6-8\]. Bacteriophages are certain viruses that naturally infect bacteria and are used as antibacterial treatments. Phagotherapy is used as antibacterial drugs that can induce lysis of target pathogens.

Key facts

Study ID

NCT06870409

Run by

University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)

People needed

30

Starts

2025-02-05

Expected to finish

2029-02-05

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalisation with active IE or active IE developed in hospital;
• Definite diagnosis of IE according to modified Duke 2023 criteria or possible diagnosis of IE but managed and treated as IE;
• Informed consent to participate in the study;

You may not qualify if…

• Inactive (transferred) IE
• Non-bacterial thrombotic endocarditis
• Active oncological diseases
• Immunosuppressive therapy

Where it is running

• University Clinical Hospital named after V.V.Vinogradov (branch) of the Peoples' Friendship University of Russia named after Patrice Lumumba — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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