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.
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
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
All patients: * Diagnosed with an MSI or CRS or persistent bacteremia or 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.
Cohort
Prospective
Prospective data collection phage therapy
Other interventionProspective data collection prior to, during and after phage treatment.
Prospective data collection standard-of-care
Other interventionProspective data collection prior to, during and after standard infection treatment.
Disease-free period
In MSI patients
Smell test
16-point Sniffin' Sticks test in CRS patients
Radiological scores
Lund-Mackay CT score in CRS patients
Endoscopic scores
Lund-Kennedy score and Modified Davos score in CRS patients
PROMIS global health
specific to MSI, CRS, Chronic Pulmonary Infection
PROMIS pain interference
specific to MSI, CRS
PROMIS physical function
specific to MSI, CRS
iMCQ
specific to MSI, CRS, Persistent bacteremia
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator
University Hospital, Antwerp
Collaborator
University Ghent
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
AZ Sint-Jan AV
Collaborator
Queen Astrid Military Hospital
Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborator
Clinique Saint Pierre Ottignies
Collaborator
Sciensano
Collaborator
