Bacteriophage therapy for hard-to-treat infections
Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force
This study is testing if a new treatment using bacteriophages can help people with tough infections that don’t respond to regular medicines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06368388 on ClinicalTrials.gov |
What this trial studies
This observational registry study evaluates the use of bacteriophage therapy for patients with difficult-to-treat infections, such as musculoskeletal infections, chronic rhinosinusitis, sepsis, pulmonary infections, and hidradenitis suppurativa. The study is conducted by a multidisciplinary task force at University Hospitals Leuven, which screens patients to determine eligibility for phage therapy when no standard treatment options are available. Patients undergo a phagogram to assess the effectiveness of available phages against their specific bacterial infections, and data is collected for long-term follow-up to analyze safety and efficacy. The study aims to optimize phage therapy protocols and develop standardized guidelines for treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with difficult-to-treat infections who have exhausted all standard treatment options and have a pathogen for which phages are available.
Not a fit: Patients with infections that are not among the specified conditions or those for whom standard treatment options are still available may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with infections that are resistant to conventional therapies.
How similar studies have performed: While bacteriophage therapy is a novel approach, there have been previous studies exploring its efficacy, indicating potential for success in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients: * Diagnosed with a musculoskeletal infection or chronic rhinosinusitis or sepsis or lung infection (CF/Bx) or hidradenitis suppurativa, and * For whom all previous treatments (surgical and antibiotic) have failed or for whom no other treatment options are available (i.e., last resort cases, based on the assessment of the CBL), for example in case of bacterial resistance. And * Of whom the pathogen causative for the infection is one for which phages are available in the phage bank, and * Who have given informed consent to have their data collected in a patient registry Exclusion Criteria: All patients: * With an infectious disease other than those mentioned above, and/or * For whom standard treatment alternatives are still available. And/or * Of whom the pathogen causative for the infection is not one for which phages are available in the phage bank. And/or * Who refused to give their informed consent
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Jolien Onsea, PhD
- Email: jolien.onsea@uzleuven.be
- Phone: 00321642041
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.