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

April 10, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Prospective data collection prior to, during and after phage treatment.
Other: Prospective data collection
Prospective data collection prior to, during and after standard infection 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.
Other: Prospective data collection
Prospective data collection prior to, during and after phage treatment.
Other: Prospective data collection
Prospective data collection prior to, during and after standard infection treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease free period
Time Frame: 1 year after treatment
1 year after treatment
Bacterial eradication
Time Frame: 3 months after treatment
specific to sepsis patients, evaluated by negative hemocultures
3 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS global health (patient-reported outcome measurement information system)
Time Frame: until 1 year after treatment
specific to musculoskeletal infections, chronic rhinosinusitis and pulmonary infections; higher scores mean better outcome
until 1 year after treatment
PROMIS (patient-reported outcome measurement information system) physical function
Time Frame: until 1 year after treatment
specific to musculoskeletal infections (higher scores mean better outcome)
until 1 year after treatment
PROMIS (patient-reported outcome measurement information system) pain interference
Time Frame: until 1 year after treatment
specific to musculoskeletal infections (higher scores mean worse outcome)
until 1 year after treatment
Sino-nasal outcome test (SNOT)-22
Time Frame: until 1 year after treatment
specific to chronic rhinosinusitis, lower scores mean a better outcome
until 1 year after treatment
Visual Analogue Scale (VAS) score
Time Frame: until 1 year after treatment
specific to chronic rhinosinusitis and hidradenitis suppurativa, higher scores mean more pain
until 1 year after treatment
Cystic fibrosis questionnaire (CF-Q-R)
Time Frame: until 1 year after treatment
specific to pulmonary infections, higher scores mean better quality of life
until 1 year after treatment
Dermatology Life Quality Index (DLQI)
Time Frame: until 1 year after treatment
specific to hidradenitis suppurativa, higher scores mean worse outcome (impaired quality of life)
until 1 year after treatment
Hidradenitis Suppurativa Quality of Life (HiSQoL)
Time Frame: until 1 year after treatment
specific to hidradenitis suppurativa, higher scores indicate a higher level of symptomatology (worse outcomes)
until 1 year after treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of exacerbations
Time Frame: until 12 months after treatment
specific to pulmonary infections
until 12 months after treatment
Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR)
Time Frame: until 3 months after treatment
specific to hidradenitis suppurativa. At least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count
until 3 months after treatment
Lund-Mackay CT score
Time Frame: until 3 months after treatment
specific to chronic rhinosinusitis, higher scores mean more occlusion
until 3 months after treatment
Lund Kennedy endoscopy score
Time Frame: until 3 months after treatment
specific to chronic rhinosinusitis, higher scores mean more occlusion
until 3 months after treatment
Modified Davos score
Time Frame: until 3 months after treatment
specific to chronic rhinosinusitis, higher scores mean more occlusion
until 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S64854

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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