An observational study in Musculoskeletal Infection, Chronic Rhinosinusitis (Diagnosis) and Persistent Bacteremia, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
Patients with difficult-to-treat musculoskeletal infections, chronic rhinosinusitis, persistent bacteremia, pulmonary infections associated with cystic fibrosis or bronchiectasis, or hidradenitis suppurativa, for whom no standard (curative) treatment options are available, are eligible for phage therapy. Patient eligibility is assessed by the multidisciplinary Coordination group for Bacteriophage therapy Leuven (CBL), in collaboration with multiple Belgian expert centers. If phages with activity against the isolated bacterial strain are identified and the patient meets all inclusion criteria, a phagogram is performed. Based on these results, patients are either assigned to receive phage therapy or remain in the control group receiving best available non-curative treatment. In both groups, standardized clinical, microbiological and health economic data are collected prospectively using REDCap.
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 100 is below the median of 170 across 72 observational studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Hidradenitis Suppurativa, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients whose isolated pathogens are susceptible to the available phages and who have no alternative curative treatment options are included in the phage-treated group. The local phage hub, in consultation with the Phage Consortium, will design the phage therapy treatment plan (local, inhalation, or intravenous) on top of standard surgical and/or antimicrobial care. The treatment plan is documented in the patient's medical file. Patients undergo monitoring according to the phage therapy protocol and follow-up according to standard care for phage-treated patients.
Other: Prospective data collection phage therapy
Patients whose isolated pathogens are not susceptible to available phages, or for whom phage therapy is not indicated, are included in the control group. These patients receive standard surgical and/or antimicrobial care as determined by the local phage hub. Monitoring and follow-up are according to the standard of care for the underlying pathology.
Other: Prospective data collection standard-of-care
Prospective data collection prior to, during and after phage treatment.
Prospective data collection prior to, during and after standard infection treatment.
Disease-free period
In MSI patients
Time frame: Until 1 year after treatment
Smell test
16-point Sniffin' Sticks test in CRS patients
Time frame: Until 1 year after treatment
Radiological scores
Lund-Mackay CT score in CRS patients
Time frame: Until 1 year after treatment
Endoscopic scores
Lund-Kennedy score and Modified Davos score in CRS patients
Time frame: Until 1 year after treatment
Time to clearance of infection
In patients with Persistent Bacteremia
Time frame: Until 1 year after treatment, daily during hospitalization until infection clearance
Overall survival
Does the patient survive (for patients with Persistent Bacteremia)
Time frame: Until 1 year after treatment
SOFA score
Sequential Organ Failure Assessment (SOFA) score in patients with persistent bacteremia, assessed to monitor changes in organ dysfunction during hospitalization.
Time frame: Baseeline and daily during hospitalization until discharge, for up to 12 weeks after cessation of phage therapy; thereafter at 6 months and 1 year after cessation of phage therapy.
Tolerance of the intervention
Proportion of patients with chronic pulmonary infection able to complete the planned phage therapy without treatment discontinuation due to adverse reactions or pulmonary exacerbations.
Time frame: During scheduled phage therapy (up to 6 weeks)
Sputum culture conversion assessed by microbiological culture
Proportion of patients with chronic pulmonary infection with conversion from a positive sputum culture for the targeted bacterial pathogen at baseline to a negative sputum culture for the targeted bacterial pathogen after phage therapy.
Time frame: Days 1-4 of phage therapy, weekly during phage therapy for up to 6 weeks, and at 6 and 12 months after completion of phage therapy.
Within-subject change in the number of positive cultures
In patients with Chronic Pulmonary Infection
Time frame: At 6 and 12 months compared to 12 months prior to therapy
Within-subject change in the number of pulmonary exacerbations requiring additional antibiotic therapy or hospitalization.
In patients with Chronic Pulmonary Infection
Time frame: At 6 and 12 months
Clinical response measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).
In patients with Chronic Pulmonary Infection
Time frame: Until 1 year after treatment
Improvement in IHS4 score
In HS patients
Time frame: Until 1 year after treatment
Improvement in ANF count using HiSCR50 and HiSCR75
In HS patients
Time frame: Until 1 year after treatment
Reduction in flare incidence compared to the 12 weeks prior to treatment.
In HS patients
Time frame: Until 1 year after treatment
Bacterial load in sinonasal material measured by quantitative microbiological culture
Bacterial load of the targeted bacterial pathogen in sinonasal samples from CRS patients quantified by microbiological culture and expressed as colony-forming units (CFU).
Time frame: Until 1 year after treatment
PROMIS global health
specific to MSI, CRS, Chronic Pulmonary Infection
Time frame: until 1 year after treatment
PROMIS pain interference
specific to MSI, CRS
Time frame: until 1 year after treatment
PROMIS physical function
specific to MSI, CRS
Time frame: until 1 year after treatment
iMCQ
specific to MSI, CRS, Persistent bacteremia
Time frame: until 1 year after treatment
iPCQ
specific to MSI, CRS, Persistent bacteremia
Time frame: until 1 year after treatment
EQ-5D-5L
specific to MSI, CRS, Persistent bacteremia, Chronic Pulmonary Infection, HS
Time frame: until 1 year after treatment
SNOT-22
specific to CRS
Time frame: until 1 year after treatment
VAS pain
specific to CRS, HS
Time frame: until 1 year after treatment
CF-Q
specific to Chronic Pulmonary Infection
Time frame: until 1 year after treatment
Bronchiectasis QoL
specific to Chronic Pulmonary Infection
Time frame: until 1 year after treatment
FEV1
specific to Chronic Pulmonary Infection
Time frame: until 1 year after treatment
FVC
specific to Chronic Pulmonary Infection
Time frame: until 1 year after treatment
DLQI
specific to HS
Time frame: until 1 year after treatment
HiSQoL
specific to HS
Time frame: until 1 year after treatment
Systemic and local phage exposure per route of administration
Specific to MSI, CRS, Chronic pulmonary infection, HS, bacteremia
Time frame: until 1 year after treatment
Duration of phage activity in blood or locally
Phage kinetics / pharmacology
Time frame: until 1 year after treatment
Change in phage-neutralizing activity measured by serum neutralization test
Phage-neutralizing activity in serum will be assessed using a serum neutralization test (adapted Adams protocol) by measuring the reduction in viable phage titer after incubation with patient serum compared with baseline. Results will be expressed as the log10 reduction in phage titer.
Time frame: until 1 year after treatment
Change in bacterial load of the targeted pathogen measured by quantitative microbiological culture
Change in bacterial load of the targeted bacterial pathogen in clinical samples collected during and after phage therapy, quantified by microbiological culture and expressed as CFU per mL.
Time frame: until 1 year after treatment
Started Jun 2021 (actual). Primary completion is estimated for Dec 2028, 90 months after the start.
Of 44 observational studies under Hidradenitis Suppurativa, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 28. This study's planned 90 months is above that.
How these figures are worked out, and which studies are left out of them.
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