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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phage treated group | 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. |
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| Control group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective data collection | Other | Prospective data collection prior to, during and after phage treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free period | 1 year after treatment | |
| Bacterial eradication | specific to sepsis patients, evaluated by negative hemocultures | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS global health (patient-reported outcome measurement information system) | specific to musculoskeletal infections, chronic rhinosinusitis and pulmonary infections; higher scores mean better outcome | until 1 year after treatment |
| PROMIS (patient-reported outcome measurement information system) physical function |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of exacerbations | specific to pulmonary infections | until 12 months after treatment |
| Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR) | 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 |
Inclusion Criteria:
All patients:
Exclusion Criteria:
All patients:
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All patients with a musculoskeletal infection or sepsis or chronic rhinosinusitis or pulmonary infection (associated with bronchiectasis or cystic fibrosis) or hidradenitis suppurativa for whom all previous treatments (anti-inflammatory/antibiotic/surgical) have failed or are likely to fail, or for whom no other treatments are available (i.e. in case of antibiotic resistance).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolien Onsea, PhD | Contact | 00321642041 | jolien.onsea@uzleuven.be | |
| Willem-Jan Metsemakers, MD, PhD | Contact | 003216344277 | willem-jan.metsemakers@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34452408 | Background | Onsea J, Uyttebroek S, Chen B, Wagemans J, Lood C, Van Gerven L, Spriet I, Devolder D, Debaveye Y, Depypere M, Dupont L, De Munter P, Peetermans WE, van Noort V, Merabishvili M, Pirnay JP, Lavigne R, Metsemakers WJ. Bacteriophage Therapy for Difficult-to-Treat Infections: The Implementation of a Multidisciplinary Phage Task Force (The PHAGEFORCE Study Protocol). Viruses. 2021 Aug 5;13(8):1543. doi: 10.3390/v13081543. |
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| Prospective data collection | Other | Prospective data collection prior to, during and after standard infection treatment. |
|
specific to musculoskeletal infections (higher scores mean better outcome) |
| until 1 year after treatment |
| PROMIS (patient-reported outcome measurement information system) pain interference | specific to musculoskeletal infections (higher scores mean worse outcome) | until 1 year after treatment |
| Sino-nasal outcome test (SNOT)-22 | specific to chronic rhinosinusitis, lower scores mean a better outcome | until 1 year after treatment |
| Visual Analogue Scale (VAS) score | specific to chronic rhinosinusitis and hidradenitis suppurativa, higher scores mean more pain | until 1 year after treatment |
| Cystic fibrosis questionnaire (CF-Q-R) | specific to pulmonary infections, higher scores mean better quality of life | until 1 year after treatment |
| Dermatology Life Quality Index (DLQI) | specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life) | 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) | until 1 year after treatment |
| until 3 months after treatment |
| Lund-Mackay CT score | specific to chronic rhinosinusitis, higher scores mean more occlusion | until 3 months after treatment |
| Lund Kennedy endoscopy score | specific to chronic rhinosinusitis, higher scores mean more occlusion | until 3 months after treatment |
| Modified Davos score | specific to chronic rhinosinusitis, higher scores mean more occlusion | until 3 months after treatment |
| ID | Term |
|---|---|
| D004194 | Disease |
| D018805 | Sepsis |
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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