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Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR. (PhagoDAIRI)

Primary Purpose

Infection of Total Hip Joint Prosthesis, Infection of Total Knee Joint Prosthesis

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Anti-Staphylococcus aureus Bacteriophages

About this trial

This is an interventional treatment trial for Infection of Total Hip Joint Prosthesis focused on measuring Joint Infection, Staphylococcus aureus, Phagotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥ 18 years
Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit
Without preoperative diagnosis of superinfection due to another pathogen
Phagogram displaying the susceptibility of the strain to at least one of the phages.
Patient with a life expectancy of 2 years and more as determined by the principal investigator
Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration
Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
Negative pregnancy test

Exclusion Criteria:

Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
Other germ found in culture of joint fluid sample
Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
Patients with ASA score ≥ 4
Severe sepsis or Septic shock or hemodynamic instability
Patients with an indication to prosthesis replacement or amputation
Immunosuppressed patients
ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women
Known allergic reactions to components of phages products
Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.

Sites / Locations

Pr Tristan FerryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bacteriophages arm

Control Arm

Arm Description

1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure.

One local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure.

Outcomes

Primary Outcome Measures

Clinical control of infection at week 12 visit

No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.

Secondary Outcome Measures

Adverse Events and Serious Adverse Events

Incidence, severity and type of adverse events and serious adverse events

Clinical laboratory tests

Number of participants with abnormal clinical laboratory tests

Physical examination

Number of participants with clinically abnormal physical examination findings

Clinical control of infection after Week 12 visit

No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid

Full Information

NCT ID

NCT05369104

First Posted

April 27, 2022

Last Updated

June 16, 2022

Sponsor

Pherecydes Pharma

1. Study Identification

Unique Protocol Identification Number

NCT05369104

Brief Title

Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.

Acronym

PhagoDAIRI

Official Title

A Pilot, Multicenter, Randomized, Non-Comparative, Double-Blind Study of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR and Antibiotic Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 16, 2023 (Anticipated)

Study Completion Date

June 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pherecydes Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection of Total Hip Joint Prosthesis, Infection of Total Knee Joint Prosthesis

Keywords

Joint Infection, Staphylococcus aureus, Phagotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This is a pilot, randomized, non-comparative, double-blind study in patients with knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT). A stratification will be performed on the affected area of arthroplasty: knee or hip and on study site.

Masking

ParticipantInvestigator

Masking Description

All persons will be blinded, except the pharmacist will be unmasking.

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bacteriophages arm

Arm Type

Experimental

Arm Description

1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure.

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

One local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure.

Intervention Type

Biological

Intervention Name(s)

Anti-Staphylococcus aureus Bacteriophages

Intervention Description

Single intra-articular injection

Primary Outcome Measure Information:

Title

Clinical control of infection at week 12 visit

Description

No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.

Time Frame

week 12 visit

Secondary Outcome Measure Information:

Title

Adverse Events and Serious Adverse Events

Description

Incidence, severity and type of adverse events and serious adverse events

Time Frame

From the time of signing the informed consent form up to study end visit (Months 24)

Title

Clinical laboratory tests

Description

Number of participants with abnormal clinical laboratory tests

Time Frame

From the time of signing the informed consent form up to study end visit (Months 24)

Title

Physical examination

Description

Number of participants with clinically abnormal physical examination findings

Time Frame

From the time of signing the informed consent form up to study end visit (Months 24)

Title

Clinical control of infection after Week 12 visit

Description

No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid

Time Frame

Month 6, Month 12, Month 18 and Month 24.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥ 18 years Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT) Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit Without preoperative diagnosis of superinfection due to another pathogen Phagogram displaying the susceptibility of the strain to at least one of the phages. Patient with a life expectancy of 2 years and more as determined by the principal investigator Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months) Negative pregnancy test Exclusion Criteria: Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation) Other germ found in culture of joint fluid sample Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages Patients with ASA score ≥ 4 Severe sepsis or Septic shock or hemodynamic instability Patients with an indication to prosthesis replacement or amputation Immunosuppressed patients ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women Known allergic reactions to components of phages products Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra TIZON

Phone

+33184861613

alexandra.tizon@pherecydes-pharma.com

Facility Information:

Facility Name

Pr Tristan Ferry

City

Lyon

ZIP/Postal Code

69004

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tristan FERRY

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.

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