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

NCT ID: NCT06368388

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Prospective data collection

Intervention Type: OTHER

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

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.

Prospective data collection

Intervention Type: OTHER

Prospective data collection prior to, during and after standard infection treatment.

Interventions

Prospective data collection

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

Intervention Type: OTHER

Prospective data collection

Prospective data collection prior to, during and after standard infection treatment.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jolien Onsea, PhD

Role: CONTACT

jolien.onsea@uzleuven.be

00321642041

Willem-Jan Metsemakers, MD, PhD

Role: CONTACT

willem-jan.metsemakers@uzleuven.be

003216344277

Facility Contacts

Jolien Onsea, PhD

Role: primary

jolien.onsea@uzleuven.be

003216342041

Willem-Jan Metsemakers, MD, PhD

Role: backup

willem-jan.metsemakers@uzleuven.be

003216344277

References

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.

Reference Type: BACKGROUND

PMID: 34452408 (View on PubMed)

Other Identifiers

S64854

Identifier Type: -

Identifier Source: org_study_id