Clinical study

EPHICACI

Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)

Status	Recruiting
Type	Observational study
Countries	Belgium
Conditions studied	Musculoskeletal Infection; Chronic Rhinosinusitis (Diagnosis); Persistent Bacteremia; Pulmonary Infection; Hidradenitis Suppurativa
Study years	2021–2029 (estimated)
Entry review	2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

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

Study description

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.

Study registrations

ClinicalTrials.gov	NCT06368388

Recorded study locations (1)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.