NCT06368388Recruiting
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
EPHICACI is a multicenter, prospective study that continues and expands the monocentric PHAGEFORCE registry initiated at UZ Leuven. In Belgium, phage therapy can be applied as standard-of-care only in patients with difficult-to-treat infections where no curative antibiotic and/or surgical alternatives are available ('last-resort cases'). A multidisciplinary phage task force, the Coordination group for Bacteriophage therapy Leuven (CBL), evaluates eligible patients, tests pathogen susceptibility, and sets up standardized treatment protocols. With EPHICACI, this approach is extended to multiple Belgian expert centers to increase patient enrollment while upholding stringent eligibility criteria. The study aims to gain insight into the safety, efficacy, biodistribution and mechanisms of action of phage therapy, and to optimize its use across five medical disciplines (with distinct routes of administration). In addition, EPHICACI integrates machine learning-based phage-bacteria interaction analyses to guide personalized phage selection, and includes health economic evaluations to support evidence-based implementation and reimbursement strategies.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 4 Apr 2024
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Cystic fibrosis
- NCT number
- NCT06368388
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Jun 2021 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- With an infectious disease other than those mentioned above, and/or
- Of whom the pathogen causative for the infection is not one for which phages are available in the phage bank. And/or
Other
- All patients:
- For whom standard treatment alternatives are still available. And/or
- Who refused to give their informed consent
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.