Ireland
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Recruiting Phase 4

Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection

NCT06172010 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 4
Started
2023-04-01
Last updated
2023-12-15

Condition(s) studied

Prosthetic-joint InfectionInfection HipInfection; Knee, Joint

Investigational drug(s) / intervention(s)

Clindamycin →Rifampicin and levofloxacin

Clindamycin: antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection

Rifampicin and levofloxacin: antimicrobial treatment in oral treatment phase of staphylococcal prosthetic joint infection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * \>18 years of age * Confirmed staphylococcal prosthetic hip or knee joint infection according to the current EBJIS 2021 definition of PJI * The causative agents are (or include) S. aureus or and/or Coagulase-negative staphylococci (CNS) * Treatment is according to the DAIR-procedure 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 for \>12 months, (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

Primary outcome measure(s)

  • treatment success — 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 antibiotics for the index joint at the end of follow-up. (IV) Death

Trial sites (13)

FacilityCityRegionStatus
LUMC Leiden Zuid Hollans Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
OLVG Amsterdam Netherlands Recruiting
Martini ziekenhuis Groningen Netherlands Not Yet Recruiting
UMCG Groningen Netherlands Recruiting
Spaarne gasthuis Hoofddorp Netherlands Recruiting
Medisch Centrum Leeuwarden Leeuwarden Netherlands Recruiting
Alrijne Ziekenhuis Leiderdorp Netherlands Recruiting
Radboud UMC Nijmegen Netherlands Recruiting
Sint maartenskliniek Nijmegen Netherlands Recruiting
Erasmus MC Rotterdam Netherlands Not Yet Recruiting
Elisabeth Tweesteden Ziekenhus Tilburg Netherlands Recruiting
Stichting Isala Klinieken Zwolle Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06172010 on ClinicalTrials.gov ↗ ← All trials in the Netherlands