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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
Prospective data collection prior to, during and after phage treatment.
Prospective data collection prior to, during and after standard infection treatment.
University Hospitals Leuven
Leuven, Belgium
RECRUITINGDisease free period
Time frame: 1 year after treatment
Bacterial eradication
specific to sepsis patients, evaluated by negative hemocultures
Time frame: 3 months after treatment
PROMIS global health (patient-reported outcome measurement information system)
specific to musculoskeletal infections, chronic rhinosinusitis and pulmonary infections; higher scores mean better outcome
Time frame: until 1 year after treatment
PROMIS (patient-reported outcome measurement information system) physical function
specific to musculoskeletal infections (higher scores mean better outcome)
Time frame: until 1 year after treatment
PROMIS (patient-reported outcome measurement information system) pain interference
specific to musculoskeletal infections (higher scores mean worse outcome)
Time frame: until 1 year after treatment
Sino-nasal outcome test (SNOT)-22
specific to chronic rhinosinusitis, lower scores mean a better outcome
Time frame: until 1 year after treatment
Visual Analogue Scale (VAS) score
specific to chronic rhinosinusitis and hidradenitis suppurativa, higher scores mean more pain
Time frame: until 1 year after treatment
Cystic fibrosis questionnaire (CF-Q-R)
specific to pulmonary infections, higher scores mean better quality of life
Time frame: until 1 year after treatment
Dermatology Life Quality Index (DLQI)
specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life)
Time frame: until 1 year after treatment
Hidradenitis Suppurativa Quality of Life (HiSQoL)
specific to hidradenitis suppurativa, higher scores indicate a higher level of symptomatology (worse outcomes)
Time frame: until 1 year after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.