PhagoDAIRI
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.
Sponsor study identifier
interventional
64
1 country
1
Study Start
June 15, 2022
Actual (reported)Primary Completion
December 16, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2022
Actual (reported)May 11, 2022
Actual (reported)June 15, 2022
Actual (reported)December 16, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
week 12 visit
Adverse Events and Serious Adverse Events
From the time of signing the informed consent form up to study end visit (Months 24)
Clinical laboratory tests
From the time of signing the informed consent form up to study end visit (Months 24)
Physical examination
From the time of signing the informed consent form up to study end visit (Months 24)
Clinical control of infection after Week 12 visit
Month 6, Month 12, Month 18 and Month 24.
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.
Single intra-articular injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pr Tristan Ferry
Lyon, 69004, France
Ferry T. A Review of Phage Therapy for Bone and Joint Infections. Methods Mol Biol. 2024;2734:207-235. doi: 10.1007/978-1-0716-3523-0_14.
First Submitted
April 27, 2022
First Posted
May 11, 2022
Study Start
June 15, 2022
Actual (reported)Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
Contact the study team to confirm eligibility.
Primary Completion
December 16, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 22, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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