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

NCT06368388 | Recruiting DMC

• 1 other identifier: S64854
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Infection; Chronic Rhinosinusitis (Diagnosis); Sepsis; Pulmonary Infection; Hidradenitis Suppurativa

Keywords

Bacteriophage therapy; Personalized treatment; Difficult-to-treat infection

Outcome Measures

Primary Outcomes (2)

• Disease free period

  1 year after treatment

• Bacterial eradication

  specific to sepsis patients, evaluated by negative hemocultures

  3 months after treatment

Secondary Outcomes (8)

• PROMIS global health (patient-reported outcome measurement information system)

  until 1 year after treatment

• PROMIS (patient-reported outcome measurement information system) physical function

  until 1 year after treatment

• PROMIS (patient-reported outcome measurement information system) pain interference

  until 1 year after treatment

• Sino-nasal outcome test (SNOT)-22

  until 1 year after treatment

• Visual Analogue Scale (VAS) score

  until 1 year after treatment

Other Outcomes (5)

• Rate of exacerbations

  until 12 months after treatment

• Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR)

  until 3 months after treatment

• Lund-Mackay CT score

  until 3 months after treatment

Study Arms (2)

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.

Other: Prospective data collection

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.

Other: Prospective data collection

Interventions

Prospective data collection OTHER

Prospective data collection prior to, during and after phage treatment.

Phage treated group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Related 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.

  PMID: 34452408 BACKGROUND

MeSH Terms

Conditions

Disease; Sepsis; Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Jolien Onsea, PhD

CONTACT

00321642041; jolien.onsea@uzleuven.be

Willem-Jan Metsemakers, MD, PhD

CONTACT

003216344277; willem-jan.metsemakers@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 16, 2024
• Study Start: June 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-03

Locations

BE (1)