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Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501620-26-00
Acronym
2022-501620-26-00
Enrollment
316
Registered
2023-02-23
Start date
2023-05-15
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prosthetic joint infection

Brief summary

treatment success 15 months after DAIR (=1 year after finishing antibiotic treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death

Detailed description

Quality of life, measured with EQ-5D-5L questionnaires. This ‘quality of life’ questionnaire will be scored at the time of randomization, at week 6 after surgical debridement and after 3 months., The number of (S)AEs during antimicrobial treatment and follow up (including mortality)., The number of switches to a different oral regimen, The number of antibiotic side effects (classified by the modified Hartwig and Siegel scale)., The number of patients developing Clostridioides difficile infection during treatment., The occurrence of rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment, The difference in absolute risks of treatment succes with death unrelated to PJI as a competing event in a per-protocol analysis, The difference in absolute risks of treatment success in an intention to treat analysis

Interventions

DRUGLevofloxacin 500 mg film-coated tablets
DRUGDoxycycline Aurobindo Disper 100 mg
DRUGCiprofloxacin-ratiopharm® 500 mg Filmtabletten
DRUGCotrimoxazol AL Sulfamethoxazol 400 mg/Trimethoprim 80 mg pro Tablette
DRUGMinocycline Teva 50 mg
DRUGClindamycin 300mg Capsules
DRUGhard

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
treatment success 15 months after DAIR (=1 year after finishing antibiotic treatment). Treatment success will be defined as absence of all of the following: (I) Infection related re-surgery of the initially affected prosthetic joint (II) New antibiotic treatment for suspected or proven infection of the index joint. (III) Ongoing use of antibiotics for the index joint at the end of follow-up. (IV) Death

Secondary

MeasureTime frame
Quality of life, measured with EQ-5D-5L questionnaires. This ‘quality of life’ questionnaire will be scored at the time of randomization, at week 6 after surgical debridement and after 3 months., The number of (S)AEs during antimicrobial treatment and follow up (including mortality)., The number of switches to a different oral regimen, The number of antibiotic side effects (classified by the modified Hartwig and Siegel scale)., The number of patients developing Clostridioides difficile infection during treatment., The occurrence of rifampicin resistance in bacteria in patients with a microbiologically confirmed failure of treatment, The difference in absolute risks of treatment succes with death unrelated to PJI as a competing event in a per-protocol analysis, The difference in absolute risks of treatment success in an intention to treat analysis

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026