Status:
COMPLETED
Short or Long Antibiotic Regimes in Orthopaedics
Lead Sponsor:
Oxford University Hospitals NHS Trust
Conditions:
Osteomyelitis
Prosthetic Joint Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Research question: If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection? Adults with bone or joi...
Detailed Description
Using antibiotics wisely, only when and where they are really needed, is important to prevent superbugs emerging. At the moment, bone and joint infections are usually treated by a combination of surge...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Aged 18 years or over
- Presenting with an orthopaedic infection, defined by one or more of the following criteria:
- localised pain, OR
- localised erythema, OR
- temperature ≥ 38.0 C, OR
- a discharging sinus or wound
- Undergoing surgical treatment for the infection
- Locally administered antibiotic(s) at the site of orthopaedic infection
- Has received \<= 7 days of systemic antimicrobial therapy after surgery
- Would ordinarily be managed with a prolonged course (\>= 4 weeks) of systemic antibiotic(s)
- Specimens for microbiological analysis taken at index surgery
Exclusion
- Surgical exclusion criteria
- The index operation was not a definitive procedure with the aim of eradicating infection:
- Primary closure has not been achieved, or
- Re-look surgery is planned
- The index operation involved implant retention (e.g. DAIR)
- Microbiological exclusion criteria
- Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection
- Medical exclusion criteria
- Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis
- If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03806166
Start Date
February 21 2019
End Date
January 31 2025
Last Update
April 3 2025
Active Locations (23)
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1
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
2
Hospital San Antonio
Porto, Portugal
3
Parc de Salut Mar
Barcelona, Spain, 08003
4
University Hospitals Dorset
Poole, Dorset, United Kingdom, BH15 2JB