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NCT06172010: RiCOTTA
Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection
Phase 4 trial testing Clindamycin in Prosthetic-joint Infection in 316 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Leiden University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 316 |
| Start date | 1 April 2023 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2028 |
| Sites | 13 locations across Netherlands |
Drugs / interventions tested
- Clindamycin (clindamycin) — full drug profile →
- Rifampicin and levofloxacin — full drug profile →
Conditions studied
- Prosthetic-joint Infection — all drugs for Prosthetic-joint Infection →
- Infection Hip — all drugs for Infection Hip →
- Infection; Knee, Joint — all drugs for Infection; Knee, Joint →
Sponsor
Leiden University Medical Center
Who can join
18 and older, any sex, with Prosthetic-joint Infection or Infection Hip. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
treatment success
Time frame: 15 months after DAIR
Proportion of patients with treatment success 15 months after DAIR (=1 year after finishing antibiotic) in both randomised groups 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 antibi
Sponsor's own description
In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin / levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing antimicrobial treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06172010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05899140 — Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial · Phase 4 · recruiting
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Other recruiting trials for Prosthetic-joint Infection
Currently open trials in the same condition.
- NCT07324954 — Methylene Blue in Total Knee Arthroplasty (TKA) · Phase 1 · recruiting
- NCT06919913 — The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of th · NA · recruiting
- NCT05642013 — SHort Interval Full Two-stage Implant Exchange · NA · recruiting
- NCT05530174 — Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture · NA · active not recruiting
- NCT05530551 — Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA · NA · active not recruiting
Other Leiden University Medical Center trials
Trials by the same sponsor.
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- NCT07090343 — Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement · Phase 3 · not yet recruiting
- NCT07498738 — Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions · NA · not yet recruiting
- NCT06545292 — Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients · NA · recruiting
- NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06172010 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Leiden University Medical Center
- Last refreshed: 6 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06172010.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing