protocolSection identificationModule nctId: NCT06368388, orgStudyIdInfo id: S64854, briefTitle: Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force, acronym: PHAGEFORCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: KU Leuven, descriptionModule briefSummary: PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration., conditionsModule conditions: Musculoskeletal Infection, conditions: Chronic Rhinosinusitis (Diagnosis), conditions: Sepsis, conditions: Pulmonary Infection, conditions: Hidradenitis Suppurativa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Prospective data collection, interventions name: Prospective data collection, outcomesModule primaryOutcomes measure: Disease free period, primaryOutcomes measure: Bacterial eradication, secondaryOutcomes measure: PROMIS global health (patient-reported outcome measurement information system), secondaryOutcomes measure: PROMIS (patient-reported outcome measurement information system) physical function, secondaryOutcomes measure: PROMIS (patient-reported outcome measurement information system) pain interference, secondaryOutcomes measure: Sino-nasal outcome test (SNOT)-22, secondaryOutcomes measure: Visual Analogue Scale (VAS) score, secondaryOutcomes measure: Cystic fibrosis questionnaire (CF-Q-R), secondaryOutcomes measure: Dermatology Life Quality Index (DLQI), secondaryOutcomes measure: Hidradenitis Suppurativa Quality of Life (HiSQoL), otherOutcomes measure: Rate of exacerbations, otherOutcomes measure: Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR), otherOutcomes measure: Lund-Mackay CT score, otherOutcomes measure: Lund Kennedy endoscopy score, otherOutcomes measure: Modified Davos score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Jolien Onsea, PhD, role: CONTACT, phone: 003216342041, email: jolien.onsea@uzleuven.be, contacts name: Willem-Jan Metsemakers, MD, PhD, role: CONTACT, phone: 003216344277, email: willem-jan.metsemakers@uzleuven.be, contacts name: Willem-Jan Metsemakers, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False