The RiCOTTA trial

Phase 1

Recruiting

• Conditions: prosthetic joint infection; MedDRA version: 20.0Level: HLTClassification code: 10005940Term: Bone and joint infections Class: 10021881; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-501620-26-00
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

All adult patients, aged 18 years or older AND, Diagnosed and hospitalized with hip- or knee prosthetic joint infection caused by Staphylococcus spp AND, Treated with DAIR: Debridement, Antibiotics and Implant Retention

Exclusion Criteria

(i)a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions) (ii)complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks (iii)An infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics) (iv)treatment failure before the start of oral therapy, (v)an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi)patients with an expected life expectancy <12 months, (vii)patients with a tumor prosthesis (viii)patients receiving chemotherapy for active malignancy in the next 12 months (ix)patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment (x)The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator (xi)Pregnancy (xii)Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study., (x)The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator, (xi)Pregnancy, (xii)Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study, (iii)An infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics), (ii)complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks, (iv)treatment failure before the start of oral therapy, (v)an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi)patients with an expected life expectancy <12 months, (vii)patients with a tumor prosthesis, (viii)patients receiving chemotherapy for active malignancy in the next 12 months, (ix)patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified