Orthopaedic infections, including chronic osteomyelitis and prosthetic joint infection) needing prolonged courses of antibiotics (6 weeks or more)and also surgical treatment MedDRA version: 20.0 Level: PT Classification code 10031252 Term: Osteomyelitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: HLT Classification code 10005941 Term: Bone and joint infections (excl arthritis) System Organ Class: 100000004859 MedDRA version: 20.0 Level: HLT Classific
Conditions
Interventions
Trade Name: Gentamicina B. Braun 1 mg/ml EFG
Product Name: GENTAMYCIN
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Gentamicin
CAS Number: 1403-66-3
Concentr
Sponsors
Oxford University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of informed consent 2) Aged 18 years or over 3) Presenting with an orthopaedic infection, defined by one or more of the following criteria: a) localised pain, OR b) localised erythema, OR c) temperature = 38.0ºC, OR d) a discharging sinus or wound 4) Undergoing surgical treatment for the infection 5) Locally administered antibiotics in a HTA-approved product or in a carrier CE marked for antibiotic delivery 6) Has received = 4 weeks) of systemic antibiotic(s) 8) Specimens for microbiological analysis taken at index surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Surgical exclusion criteria 1) The index operation was not a definitive procedure with the aim of eradicating infection: a) Primary closure has not been achieved, or b) Re-look surgery is planned 2) The index operation involved implant retention (e.g. DAIR) Microbiological exclusion criteria 3) 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 4) Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis. 5) If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if local antibiotics combined with short course systemic antibiotics (=4 weeks) in the management of acute or chronic bone and joint infection, as judged by the proportion of patients experiencing treatment failure at 1 year follow-up.;Secondary Objective: To compare: 1) Possible or probable treatment failure 2) Incidence of serious adverse events (including death), 3) Antibiotic-related side effects 4) Resource allocation (length of inpatient hospital stay, frequency of outpatient visits, antibiotic prescribing) 5) Patient reported outcome measures 6) Deviation from allocated treatment strategy;Primary end point(s): The primary endpoint will be definitive treatment failure within 12 months of surgery, as determined by a blinded endpoint committee using redacted information from the patient record. Definite treatment failure is defined by one or more of the following: 1) The isolation by culture of micro-organisms from 2 or more samples of bone/peri-prosthetic tissue from the site of incident infection at re-operation, where the micro-organisms are phenotypically indistinguishable*. 2) A pathogenic organism (e.g. Staphylococcus aureus but not Staphylococcus epidermidis) on a single, closed, biopsy or aspirate from the site of incident infection. 3) Histology diagnostic of infection from bone/peri-prosthetic tissue obtained at re-operation at the site of incident infection. 4) Formation of a sinus tract arising from the bone/prosthesis/orthopaedic device identified at clinical review or re-operation. 5) Recurrence of frank pus adjacent to bone/prosthesis/orthopaedic device identified at re-operation or aspiration 6) Elevated synovial fluid White Cell Count or neutrophil percentage, or ++ change on leucocyte esterase strip, from prosthetic joint site affected by incident infection, at re-operation or aspiration. 7) Death resulting from orthopaedic infection at the incident anatomic site. * indistinguishable refers to the results of routin | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Within 12 months of surgery;Secondary end point(s): Secondary endpoints will be: 1) Probable treatment failure and possible treatment failure 2) Serious Adverse Events (SAEs), including death (i.e. all-cause mortality) 3) Antibiotic side effects 4) Resource allocation using (a) length of inpatient hospital stay, (b) frequency of outpatient visits, (c) antibiotic prescribing costs, In-hospital treatment cost. 5) Quality of life as evaluated by the patient reported outcome measures on the EQ-5D-5L questionnaire, at baseline and 1 year follow-up 6) Deviation from allocated treatment strategy, (including early termination of systemic antibiotics) because of adverse events, patient preference or any other reason | — |
Countries
Spain, United Kingdom
Contacts
Public ContactDr. Matthew Scarborough
xford University Hospitals NHS Foundation Trust
Outcome results
None listed