RecruitingNCT06368388

Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)

Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

100 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

EPHICACI is a multicenter, prospective study that continues and expands the monocentric PHAGEFORCE registry initiated at UZ Leuven. In Belgium, phage therapy can be applied as standard-of-care only in patients with difficult-to-treat infections where no curative antibiotic and/or surgical alternatives are available ('last-resort cases'). A multidisciplinary phage task force, the Coordination group for Bacteriophage therapy Leuven (CBL), evaluates eligible patients, tests pathogen susceptibility, and sets up standardized treatment protocols. With EPHICACI, this approach is extended to multiple Belgian expert centers to increase patient enrollment while upholding stringent eligibility criteria. The study aims to gain insight into the safety, efficacy, biodistribution and mechanisms of action of phage therapy, and to optimize its use across five medical disciplines (with distinct routes of administration). In addition, EPHICACI integrates machine learning-based phage-bacteria interaction analyses to guide personalized phage selection, and includes health economic evaluations to support evidence-based implementation and reimbursement strategies.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Prospective data collection phage therapy and Prospective data collection standard-of-care for people with chronic rhinosinusitis (diagnosis), hidradenitis suppurativa, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERProspective data collection phage therapy

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

OTHERProspective data collection standard-of-care

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


Locations(1)

University Hospitals Leuven

Leuven, Belgium

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NCT06368388


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