Plain English Summary
Background and study aims
Bone and joint infections (BJI) result from a host of different causes, can have very different symptoms and prognoses and need to be treated in different ways. Some, such as uncomplicated childhood osteomyelitis (a bone infection), can be very successfully treated with a short course of antibiotics. In contrast, in some situations such as chronic implant-associated BJI, the pathogen (agent causing the infection) is difficult to eradicate, meaning it is likely to come back despite surgery and prolonged intravenous antibiotic therapy (fed though a drip). In such cases, team-work in specialist hospitals (or tertiary care centers) is required to determine how best to treat the patient to avoid failure, long-lasting disability and risk of amputation. The choice of antimicrobial therapy is also challenging, due to bone diffusion (the antibiotic diffusing into bone tissue), having to use antibiotics that work against bacterial biofilms (that is, bacteria that can stick to surfaces, such as bone), antibiotic resistance and the high risk of severe adverse events (SAE) (side effects). Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is frequently required as salvage therapy (therapy for a condition that doesn’t respond to standard therapy) in complex BJI. This study looks at the safety of daptomycin and how successful it is at treating BJI.
Who can participate?
Adults with complex BJI.
What does the study involve?
Each participant is given high doses (>6 mg/kg/day) of daptomycin for as long as is deemed necessary but the physician. Each patient is then followed up to see if the treatment worked and whether they suffered any serious side effects.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Hospices Civils de Lyon (France)
When is the study starting and how long is it expected to run for?
January 2011 to July 2013
Who is funding the study?
Hospices Civils de Lyon (France)
Who is the main contact?
Professor Tristan Ferry
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Daptomycin > 6 mg/kg/day in complex bone and joint infection: prospective cohort study in a regional reference center
Acronym
Study hypothesis
Safety and efficacy of daptomycin in patients with complex bone and joint infection
Ethics approval
Committee for the Protection of Persons Sud Est III (CPP Sud Est III), ref: QH 20/2014
Study design
Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Complex bone and joint infection
Intervention
A prescription of high doses (>6 mg/kg/day) of daptomycin for complex bone and joint infection. There is only one arm. The total duration is based on the physician decision, and the follow up is based on the usual clinical practice.
Intervention type
Phase
Drug names
Primary outcome measure
Rate of treatment failure that occurred either during the treatment of after the discontinuation of the treatment. Factors associated with treatment failure were determined on univariate Cox analysis and Kaplan-Meier curves.
Secondary outcome measures
Occurence of serious adverse events
Overall trial start date
01/01/2011
Overall trial end date
01/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with complex BJI managed in the trial participating centre and for whom the need for a treament with daptomycin has been validated in a multidisciplinary meeting
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
43
Participant exclusion criteria
N/A
Recruitment start date
01/01/2011
Recruitment end date
01/07/2013
Locations
Countries of recruitment
France
Trial participating centre
Hospices Civils de Lyon
69004
France
Funders
Funder type
Hospital/treatment centre
Funder name
Hospices Civils de Lyon
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The article has been accepted for publication in BMC Infectious Disease, but the editor would like us to register this trial before publication
Intention to publish date
29/02/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26888539