Chronic Rhinosinusitis (Diagnosis), Hidradenitis Suppurativa, Musculoskeletal Infection, Pulmonary Infection, Sepsis
Conditions
Keywords
Bacteriophage therapy, Personalized treatment, Difficult-to-treat infection
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.
Interventions
Prospective data collection prior to, during and after phage treatment.
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free period | 1 year after treatment | — |
| Bacterial eradication | 3 months after treatment | specific to sepsis patients, evaluated by negative hemocultures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cystic fibrosis questionnaire (CF-Q-R) | until 1 year after treatment | specific to pulmonary infections, higher scores mean better quality of life |
| Dermatology Life Quality Index (DLQI) | until 1 year after treatment | specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life) |
| 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) |
| 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 |
| PROMIS (patient-reported outcome measurement information system) physical function | until 1 year after treatment | specific to musculoskeletal infections (higher scores mean better outcome) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lund Kennedy endoscopy score | until 3 months after treatment | specific to chronic rhinosinusitis, higher scores mean more occlusion |
| Modified Davos score | until 3 months after treatment | specific to chronic rhinosinusitis, higher scores mean more occlusion |
| Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR) | until 3 months after treatment | specific to hidradenitis suppurativa. At least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count |
| Lund-Mackay CT score | until 3 months after treatment | specific to chronic rhinosinusitis, higher scores mean more occlusion |
| Rate of exacerbations | until 12 months after treatment | specific to pulmonary infections |
Countries
Belgium
Contacts
Primary ContactJolien Onsea, PhD
Backup ContactWillem-Jan Metsemakers, MD, PhD
Outcome results
None listed