Using bacteriophages with antibiotics to treat infective endocarditis
A Prospective Interventional Randomized Placebo-controlled Multicenter Clinical Trial of the Efficacy, Tolerability and Safety of Phage Therapy in Combination With Standard Antibiotic Therapy in Patients With Infective Endocarditis
This study is testing whether using a special virus called bacteriophages along with antibiotics can help people with a serious heart infection called infective endocarditis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba) Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06870409 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of bacteriophages in conjunction with antibiotics for patients suffering from infective endocarditis, a serious heart infection caused by bacteria. The study aims to address the growing issue of antibiotic resistance by utilizing bacteriophages, which are viruses that specifically target and kill bacteria. Participants will be hospitalized patients diagnosed with active infective endocarditis, and the trial will assess the effectiveness of this combined treatment approach. The methodology includes monitoring the efficacy of bacteriophage therapy alongside standard antibiotic treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients with a confirmed diagnosis of active infective endocarditis.
Not a fit: Patients with inactive infective endocarditis or those undergoing immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with antibiotic-resistant infections.
How similar studies have performed: While bacteriophage therapy is a relatively novel approach, previous studies have shown promise in treating antibiotic-resistant infections, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; Exclusion Criteria: * Inactive (transferred) IE * Non-bacterial thrombotic endocarditis * Active oncological diseases * Immunosuppressive therapy
Where this trial is running
Moscow
- University Clinical Hospital named after V.V.Vinogradov (branch) of the Peoples' Friendship University of Russia named after Patrice Lumumba — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Zhanna Davidovna Kobalava, Head of Internal Disease Unit
- Email: zkobalava@mail.ru
- Phone: +7(985)7848454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.