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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
View:

⁃ 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

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Contact Information
Primary
Jolien Onsea, PhD
jolien.onsea@uzleuven.be
00321642041
Backup
Willem-Jan Metsemakers, MD, PhD
willem-jan.metsemakers@uzleuven.be
003216344277
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 50
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven

This content was sourced from clinicaltrials.gov