Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force
- Conditions
- Chronic Rhinosinusitis (Diagnosis)Musculoskeletal InfectionHidradenitis SuppurativaPulmonary InfectionSepsis
- Interventions
- Other: Prospective data collection
- Registration Number
- NCT06368388
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
Patients with difficult-to-treat musculoskeletal infections, chronic rhinosinusitis, sepsis, 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 evaluated by the Coordination group for Bacteriophage therapy Leuven. If phages are available against the isolated bacterial species and the patient is found eligible for phage therapy, a phagogram is performed. Solely based on the results of the phagogram, the patient is either included in the phage treated or control group (standard (non-curative) treatment). In both cases, data is collected using REDCap.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
All patients:
- Diagnosed with a musculoskeletal infection or chronic rhinosinusitis or sepsis or lung infection (CF/Bx) or hidradenitis suppurativa, 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 CBL), 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Prospective data collection Patients for whom the isolated pathogens are not susceptible to the available phages are included in the control group. These patients receive standard (non-curative) surgical/antimicrobial treatment. Phage treated group Prospective data collection Solely depending on the susceptibility of the isolates against the available phages (phagogram) the CBL will decide if the patient can be included in the phage treated group or the control group. Patients in the phage treated group will receive phage therapy according to the medical indication (local for musculoskeletal infections, hidradenitis suppurativa and CRS, through inhalation for pulmonary infections, intravenous for sepsis) on top of (surgical/antimicrobial) standard treatment.
- Primary Outcome Measures
Name Time Method Bacterial eradication 3 months after treatment specific to sepsis patients, evaluated by negative hemocultures
Disease free period 1 year after treatment
- Secondary Outcome Measures
Name Time Method Cystic fibrosis questionnaire (CF-Q-R) until 1 year after treatment specific to pulmonary infections, higher scores mean better quality of life
PROMIS global health (patient-reported outcome measurement information system) until 1 year after treatment specific to musculoskeletal infections, chronic rhinosinusitis and pulmonary infections; higher scores mean better outcome
Dermatology Life Quality Index (DLQI) until 1 year after treatment specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life)
PROMIS (patient-reported outcome measurement information system) physical function until 1 year after treatment specific to musculoskeletal infections (higher scores mean better outcome)
PROMIS (patient-reported outcome measurement information system) pain interference until 1 year after treatment specific to musculoskeletal infections (higher scores mean worse outcome)
Sino-nasal outcome test (SNOT)-22 until 1 year after treatment specific to chronic rhinosinusitis, lower scores mean a better outcome
Visual Analogue Scale (VAS) score until 1 year after treatment specific to chronic rhinosinusitis and hidradenitis suppurativa, higher scores mean more pain
Hidradenitis Suppurativa Quality of Life (HiSQoL) until 1 year after treatment specific to hidradenitis suppurativa, higher scores indicate a higher level of symptomatology (worse outcomes)
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Belgium