Actively Recruiting
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Led by Leiden University Medical Center · Updated on 2023-12-15
316
Participants Needed
13
Research Sites
256 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
U
University Medical Center Groningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age
- Confirmed staphylococcal prosthetic hip or knee joint infection according to EBJIS 2021 definition
- Infection caused by Staphylococcus aureus or Coagulase-negative staphylococci
- Treated using the DAIR surgical procedure
You will not qualify if you...
- Contraindication for rifampicin, such as resistant strain, allergy, or drug interactions
- Complicated Staphylococcus aureus bacteremia or endocarditis needing more than 2 weeks of intravenous antibiotics
- Infection that requires only intravenous antibiotics with no suitable oral options
- Treatment failure before starting oral therapy
- Poor response leading to intravenous therapy continued beyond 21 days
- Expected life expectancy less than 12 months
- Presence of a tumor prosthesis
- Receiving chemotherapy for active cancer in the next 12 months
- Scheduled for chronic suppressive antibiotic therapy longer than 12 months
- Unlikely to comply with trial requirements as judged by the investigator
- Pregnancy
- Inability to read or communicate in Dutch or English
AI-Screening
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Trial Site Locations
Total: 13 locations
1
LUMC
Leiden, Zuid Hollans, Netherlands, 2333ZA
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
3
OLVG
Amsterdam, Netherlands
Actively Recruiting
4
Martini ziekenhuis
Groningen, Netherlands
Not Yet Recruiting
5
UMCG
Groningen, Netherlands
Actively Recruiting
6
Spaarne gasthuis
Hoofddorp, Netherlands
Actively Recruiting
7
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
8
Alrijne Ziekenhuis
Leiderdorp, Netherlands
Actively Recruiting
9
Radboud UMC
Nijmegen, Netherlands
Actively Recruiting
10
Sint maartenskliniek
Nijmegen, Netherlands
Actively Recruiting
11
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
12
Elisabeth Tweesteden Ziekenhus
Tilburg, Netherlands
Actively Recruiting
13
Stichting Isala Klinieken
Zwolle, Netherlands
Actively Recruiting
Research Team
H
Henk Scheper, MD
CONTACT
M
Mark De Boer, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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