Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368388
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-04
Brief Title:
Bacteriophage Therapy for Difficult-to-treat Infections the Implementation of a Multidisciplinary Phage Task Force
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Bacteriophage Therapy for Difficult-to-treat Infections the Implementation of a Multidisciplinary Phage Task Force
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAGEFORCE
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None