Clinical trial Recruiting at 1 site Observational

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 typeObservational
SexAll
Enrollment100 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedJune 1, 2021
Main results expectedDecember 31, 2028
Study endsDecember 31, 2029
Registry record updatedSeptember 21, 2026
Trial IDNCT06368388 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.