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PhagoDAIR I : 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.
EU CTIS ID: 2024-516207-17-00
What this study is testing
To estimate the rate of clinical control of infection due to Staphylococcus aureus of two different therapeutic regimens: DAIR + curative antibiotics therapy combined with bacteriophages or solution of NaCl 0.9%; in patients presenting a Prosthesis Joint Infection (PJI) later than 1 month after the arthroplasty, with the indication of DAIR + Suppressive Antibiotics Therapy (SAT) which will allow to calculate the sample size for future comparative studies.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥ 18 years
- Negative pregnancy test
- Signing a written informed consent before any study related procedures
- Affiliated to a national social security system and / or private health insurance in compliance with the recommendations of National Law in force relating to biomedical research
- Staphylococcus aureus monomicrobial knee or hip PJI > 1 month after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure (if associated flap, arthrotomy must be sealed), 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
You likely can't join if
- Early Staphylococcus aureus Prosthesis Joint infection ( < 1 month after the prosthesis implantation)
- Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- Patient who, in the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Currently in exclusion period from a previous study
- Concomitant participation to another interventional clinical trial or previous participation with active drug levels still present, i.e. the last medication intake is less than 4 half-lives ago
- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and up to 1 month after the last administration of study drug
See the full eligibility criteria
- Male or female ≥ 18 years
- Negative pregnancy test
- Signing a written informed consent before any study related procedures
- Affiliated to a national social security system and / or private health insurance in compliance with the recommendations of National Law in force relating to biomedical research
- Staphylococcus aureus monomicrobial knee or hip PJI > 1 month after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure (if associated flap, arthrotomy must be sealed), 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 if treatment is administered at the end of the DAIR
- Without diagnosis of superinfection due to another pathogen identified within 72h after a bacteriological sample performed during a DAIR if treatment is administered 14±2 days after a DAIR.
- 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 effective method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, condom) 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)
- Early Staphylococcus aureus Prosthesis Joint infection ( < 1 month after the prosthesis implantation)
- Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- Patient who, in the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Currently in exclusion period from a previous study
- Concomitant participation to another interventional clinical trial or previous participation with active drug levels still present, i.e. the last medication intake is less than 4 half-lives ago
- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and up to 1 month after the last administration of study drug
- Women/Men refusing to use an acceptable effective contraception during 1 month after the last administration of study drug
- No possibility of contact in case of emergency
- Minors, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care and persons admitted to a health or social institution, to adult patient under legal protection or unable to express consent.
- Other germ found in culture of joint fluid sample
- 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
- Known allergic reactions to components of phages products
- Relapse between DAIR and treatment administration planned 14±2 days after a DAIR
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.