Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force

Sepsis Clinical Trial

— PHAGEFORCE  

Official title:

Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368388
• Other study ID #: S64854
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Jolien Onsea, PhD
• Phone: 00321642041
• Email: jolien.onsea[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Communicable Diseases
• Hidradenitis
• Hidradenitis Suppurativa
• Infections
• Musculoskeletal Infection
• Pulmonary Infection
• Rhinosinusitis
• Sepsis

Intervention

Other:
• Prospective data collection
Prospective data collection prior to, during and after phage treatment.
• Prospective data collection
Prospective data collection prior to, during and after standard infection treatment.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of exacerbations	specific to pulmonary infections	until 12 months after treatment
Other	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	until 3 months after treatment
Other	Lund-Mackay CT score	specific to chronic rhinosinusitis, higher scores mean more occlusion	until 3 months after treatment
Other	Lund Kennedy endoscopy score	specific to chronic rhinosinusitis, higher scores mean more occlusion	until 3 months after treatment
Other	Modified Davos score	specific to chronic rhinosinusitis, higher scores mean more occlusion	until 3 months after treatment
Primary	Disease free period		1 year after treatment
Primary	Bacterial eradication	specific to sepsis patients, evaluated by negative hemocultures	3 months after treatment
Secondary	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
Secondary	PROMIS (patient-reported outcome measurement information system) physical function	specific to musculoskeletal infections (higher scores mean better outcome)	until 1 year after treatment
Secondary	PROMIS (patient-reported outcome measurement information system) pain interference	specific to musculoskeletal infections (higher scores mean worse outcome)	until 1 year after treatment
Secondary	Sino-nasal outcome test (SNOT)-22	specific to chronic rhinosinusitis, lower scores mean a better outcome	until 1 year after treatment
Secondary	Visual Analogue Scale (VAS) score	specific to chronic rhinosinusitis and hidradenitis suppurativa, higher scores mean more pain	until 1 year after treatment
Secondary	Cystic fibrosis questionnaire (CF-Q-R)	specific to pulmonary infections, higher scores mean better quality of life	until 1 year after treatment
Secondary	Dermatology Life Quality Index (DLQI)	specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life)	until 1 year after treatment
Secondary	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