Bacteriophage therapy for hard-to-treat infections
Official title: Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections
Run by Universitaire Ziekenhuizen KU Leuven · NCT06368388 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT06368388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While bacteriophage therapy is a novel approach, there have been previous studies exploring its efficacy, indicating potential for success in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Diagnosed with an MSI or CRS or persistent bacteremia or pulmonary infection (cystic fibrosis/bronchiectasis) or HS 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 local phage hub), 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 it's running
-
University Hospitals Leuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Willem-Jan Metsemakers, MD, PhD — UZ / KU Leuven
- Study coordinator: Jolien Onsea, PhD
- Email: jolien.onsea@uzleuven.be
- Phone: 00321642041
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AI-powered CT help to guide pneumonia care
A multicenter trial tests whether using a chest CT–based AI report to guide care reduces death or need for new organ support in adults with pneumonia.
-
BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults
This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.
-
Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight
This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.
-
Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa
This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.
-
LAD328 in adults with hidradenitis suppurativa
This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.
-
Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy
This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.