Could viruses be the new antibiotics for joint infections?
NCT ID NCT06605651
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a treatment using special viruses (called phages) can safely and effectively treat infections in hip or knee replacements caused by Staphylococcus aureus bacteria. About 100 adults will receive either the phage therapy or a placebo during a standard surgery to clean the joint. The goal is to control the infection and reduce the need for long-term antibiotics.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female ≥ 18 years 2. Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines 3. Monobacterial Infection due to S. aureus 4. Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant) 5. Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR 6. Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator 7. S. aureus in joint fluid during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion 8. Patient with a life expectancy of 1 year or more as determined by the principal investigator. 9. 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 until 1 month after the last study drug administration. 10. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months) Exclusion Criteria: 1. Relapse between DAIR and study drug administration planned up to 14 days after the DAIR. 2. Patients who have two planned DAIR in sequence (double DAIR) 3. Patients with ASA score ≥ 4 4. Severe sepsis or Septic shock or hemodynamic instability 5. Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation 6. Indication for suppressive antibiotherapy 7. Immunosuppressed patients: Patients having a weakened immune system due to diseases conditions (i.e. genetic disorders, malnutrition) or treatment (i.e. anticancer drugs or organ transplant) 8. Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C 9. Previous treatment by bacteriophages 10. Any known phage allergy and/or to its excipients 11. Elevated ALT or AST above 4 times ULN
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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