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

NCT06870409 | Recruiting Phase 3

• 1 other identifier: BP-IE-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endocarditis, Bacterial

Keywords

infective endocarditis; bacteriophages

Outcome Measures

Primary Outcomes (1)

• Frequency of the combined endpoint (duration of hospitalisation > 14 days , hospital embolic events and death) in patients with IE receiving adjunctive therapy with bacteriophage complex preparation in combination with standard antibiotic therapy

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients with infective endocarditis will receive a placebo in addition to standard antibiotic therapy

Drug: Bacteriophage

Bacteriophage

EXPERIMENTAL

Group of patients who will be supplemented with bacteriophage complex drug in addition to standard antibiotic therapy

Drug: Bacteriophage

Interventions

Bacteriophage DRUG

Complex drug of 3-4 virulent phages to each type of bacteria, active against: * Staphylococcus spp. \[Staphylococcus aureus, CoNS (S. epidermidis, S. haemolyticus, S. hominis, S. warneri, S. capitis)\]. * Streptococcus spp. \[Streptococcus viridans (Str. mutans, Str. sanguis, Str. mitis, Str. cristatus, Str. gordonii, Str. oralis, Str. salivarius), Gemella hemolysans, Str. bovis (Str. gallolyticus), Str. constellatus, Str. anginosus, Str. agalactiae\]. * Enterococcus spp. \[E. faecalis, E. faecium\]. * Non-HACEK \[E. coli, A. baumanii, K. pneumoniae, P. aeruginosa\]

Bacteriophage; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

University Clinical Hospital named after V.V.Vinogradov (branch) of the Peoples' Friendship University of Russia named after Patrice Lumumba

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Endocarditis, Bacterial; Endocarditis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Heart Diseases

Central Study Contacts

Zhanna Davidovna Kobalava, Head of Internal Disease Unit

CONTACT

+7(985)7848454; zkobalava@mail.ru

Elizaveta Olegovna Kotova, MD in cardiology department

CONTACT

+79268399956; mauschen@inbox.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): February 5, 2028
• Study Completion (Estimated): February 5, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: unlimited
• Access Criteria: anyone

Locations

RU (1)