[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544400":3},{"organization":4,"outcomesModule":7,"designInfo":111,"detailedDescription":114,"studyPopulation":115,"armGroups":116,"interventions":127,"overallOfficials":136,"centralContacts":141,"locations":150,"responsibleParty":169,"collaborators":171,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":110,"maxAge":110,"enrollmentInfo":200,"targetDuration":203,"studyType":204,"phases":110,"briefSummary":205,"conditions":206,"keywords":212,"overallStatus":153,"whyStopped":110,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":60,"otherOutcomes":110},[9,13,16,19,22,26,29,33,37,41,45,48,50,53,55,57],{"measure":10,"description":11,"timeFrame":12},"Disease-free period","In MSI patients","Until 1 year after treatment",{"measure":14,"description":15,"timeFrame":12},"Smell test","16-point Sniffin' Sticks test in CRS patients",{"measure":17,"description":18,"timeFrame":12},"Radiological scores","Lund-Mackay CT score in CRS patients",{"measure":20,"description":21,"timeFrame":12},"Endoscopic scores","Lund-Kennedy score and Modified Davos score in CRS patients",{"measure":23,"description":24,"timeFrame":25},"Time to clearance of infection","In patients with Persistent Bacteremia","Until 1 year after treatment, daily during hospitalization until infection clearance",{"measure":27,"description":28,"timeFrame":12},"Overall survival","Does the patient survive (for patients with Persistent Bacteremia)",{"measure":30,"description":31,"timeFrame":32},"SOFA score","Sequential Organ Failure Assessment (SOFA) score in patients with persistent bacteremia, assessed to monitor changes in organ dysfunction during hospitalization.","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.",{"measure":34,"description":35,"timeFrame":36},"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.","During scheduled phage therapy (up to 6 weeks)",{"measure":38,"description":39,"timeFrame":40},"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.","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.",{"measure":42,"description":43,"timeFrame":44},"Within-subject change in the number of positive cultures","In patients with Chronic Pulmonary Infection","At 6 and 12 months compared to 12 months prior to therapy",{"measure":46,"description":43,"timeFrame":47},"Within-subject change in the number of pulmonary exacerbations requiring additional antibiotic therapy or hospitalization.","At 6 and 12 months",{"measure":49,"description":43,"timeFrame":12},"Clinical response measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).",{"measure":51,"description":52,"timeFrame":12},"Improvement in IHS4 score","In HS patients",{"measure":54,"description":52,"timeFrame":12},"Improvement in ANF count using HiSCR50 and HiSCR75",{"measure":56,"description":52,"timeFrame":12},"Reduction in flare incidence compared to the 12 weeks prior to treatment.",{"measure":58,"description":59,"timeFrame":12},"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).",[61,65,68,70,73,75,78,81,84,87,89,91,93,96,98,101,104,107],{"measure":62,"description":63,"timeFrame":64},"PROMIS global health","specific to MSI, CRS, Chronic Pulmonary Infection","until 1 year after treatment",{"measure":66,"description":67,"timeFrame":64},"PROMIS pain interference","specific to MSI, CRS",{"measure":69,"description":67,"timeFrame":64},"PROMIS physical function",{"measure":71,"description":72,"timeFrame":64},"iMCQ","specific to MSI, CRS, Persistent bacteremia",{"measure":74,"description":72,"timeFrame":64},"iPCQ",{"measure":76,"description":77,"timeFrame":64},"EQ-5D-5L","specific to MSI, CRS, Persistent bacteremia, Chronic Pulmonary Infection, HS",{"measure":79,"description":80,"timeFrame":64},"SNOT-22","specific to CRS",{"measure":82,"description":83,"timeFrame":64},"VAS pain","specific to CRS, HS",{"measure":85,"description":86,"timeFrame":64},"CF-Q","specific to Chronic Pulmonary Infection",{"measure":88,"description":86,"timeFrame":64},"Bronchiectasis QoL",{"measure":90,"description":86,"timeFrame":64},"FEV1",{"measure":92,"description":86,"timeFrame":64},"FVC",{"measure":94,"description":95,"timeFrame":64},"DLQI","specific to HS",{"measure":97,"description":95,"timeFrame":64},"HiSQoL",{"measure":99,"description":100,"timeFrame":64},"Systemic and local phage exposure per route of administration","Specific to MSI, CRS, Chronic pulmonary infection, HS, bacteremia",{"measure":102,"description":103,"timeFrame":64},"Duration of phage activity in blood or locally","Phage kinetics \u002F pharmacology",{"measure":105,"description":106,"timeFrame":64},"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.",{"measure":108,"description":109,"timeFrame":64},"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.",null,{"allocation":110,"interventionModel":110,"interventionModelDescription":110,"primaryPurpose":110,"observationalModel":112,"timePerspective":113,"maskingInfo":110},"COHORT","PROSPECTIVE","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.","All patients:\n\n* Diagnosed with an MSI or CRS or persistent bacteremia or or pulmonary infection (cystic fibrosis\u002Fbronchiectasis) or HS and\n* 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\n* Of whom the pathogen causative for the infection is one for which phages are available in the phage bank, and\n* Who have given informed consent to have their data collected in a patient registry.",[117,122],{"label":118,"type":110,"description":119,"interventionNames":120},"Phage treated group","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\u002For 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.",[121],"Other: Prospective data collection phage therapy",{"label":123,"type":110,"description":124,"interventionNames":125},"Control group","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\u002For antimicrobial care as determined by the local phage hub. Monitoring and follow-up are according to the standard of care for the underlying pathology.",[126],"Other: Prospective data collection standard-of-care",[128,132],{"type":6,"name":129,"description":130,"armGroupLabels":131,"otherNames":110},"Prospective data collection phage therapy","Prospective data collection prior to, during and after phage treatment.",[118],{"type":6,"name":133,"description":134,"armGroupLabels":135,"otherNames":110},"Prospective data collection standard-of-care","Prospective data collection prior to, during and after standard infection treatment.",[123],[137],{"name":138,"affiliation":139,"role":140},"Willem-Jan Metsemakers, MD, PhD","UZ \u002F KU Leuven","PRINCIPAL_INVESTIGATOR",[142,147],{"name":143,"role":144,"phone":145,"phoneExt":110,"email":146},"Jolien Onsea, PhD","CONTACT","00321642041","jolien.onsea@uzleuven.be",{"name":138,"role":144,"phone":148,"phoneExt":110,"email":149},"003216344277","willem-jan.metsemakers@uzleuven.be",[151],{"facility":152,"status":153,"city":154,"state":110,"zip":155,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":163,"contacts":164},"University Hospitals Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":159,"coordinates":160},"Point",[161,162],4.70093,50.87959,{"lat":162,"lon":161},[165,167,168],{"name":143,"role":144,"phone":166,"phoneExt":110,"email":146},"003216342041",{"name":138,"role":144,"phone":148,"phoneExt":110,"email":149},{"name":138,"role":140,"phone":110,"phoneExt":110,"email":110},{"type":170,"investigatorFullName":110,"investigatorTitle":110,"investigatorAffiliation":110,"oldNameTitle":110,"oldOrganization":110},"SPONSOR",[172,174,176,178,180,182,184,186,188],{"name":173,"class":6},"KU Leuven",{"name":175,"class":6},"University Hospital, Antwerp",{"name":177,"class":6},"University Ghent",{"name":179,"class":6},"Universitair Ziekenhuis Brussel",{"name":181,"class":6},"AZ Sint-Jan AV",{"name":183,"class":6},"Queen Astrid Military Hospital",{"name":185,"class":6},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"name":187,"class":6},"Clinique Saint Pierre Ottignies",{"name":189,"class":190},"Sciensano","OTHER_GOV","100544400","bacteriophage-therapy-for-difficult-to-treat-infections-the-implementation-of-a-multidisciplinary-phage-task-force-100544400",false,"NCT06368388","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","EPHICACI","Inclusion criteria\n\n* Diagnosed with an MSI or CRS or persistent bacteremia or pulmonary infection (cystic fibrosis\u002Fbronchiectasis) or HS and\n* 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\n* Of whom the pathogen causative for the infection is one for which phages are available in the phage bank, and\n* Who have given informed consent to have their data collected in a patient registry\n\nExclusion Criteria:\n\nAll patients:\n\n* With an infectious disease other than those mentioned above, and\u002For\n* For whom standard treatment alternatives are still available. And\u002For\n* Of whom the pathogen causative for the infection is not one for which phages are available in the phage bank. And\u002For\n* Who refused to give their informed consent","ALL",{"count":201,"type":202},100,"ESTIMATED","1 Year","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\u002For 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.",[207,208,209,210,211],"Musculoskeletal Infection","Chronic Rhinosinusitis (Diagnosis)","Persistent Bacteremia","Pulmonary Infection","Hidradenitis Suppurativa",[213,214,215,216,217,218,219,220,221,222,223],"Bacteriophage therapy","Personalized treatment","Difficult-to-treat infection","Antimicrobial resistance","Musculoskeletal infections","Chronic rhinosinusitis","Persistent bacteremia","Pulmonary infections","Cystic fibrosis","Bronchiectasis","Hidradenitis suppurativa","2026-09-15",{"date":226,"type":227},"2026-09-21","ACTUAL",{"date":229,"type":227},"2021-06-01",{"date":231,"type":202},"2029-12-31",{"name":5,"class":6},1]