Daptomycin > 6 mg/kg/day in complex bone and joint infection
| ISRCTN | ISRCTN14244698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14244698 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2016
- Registration date
- 28/01/2016
- Last edited
- 30/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Service de Maladies Infectieuses
Hôpital de la Croix-Rousse
93 grande rue de la Croix-Rousse
Lyon
69004
France
Study information
| Study design | Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Daptomycin > 6 mg/kg/day in complex bone and joint infection: prospective cohort study in a regional reference center |
| Study objectives | Safety and efficacy of daptomycin in patients with complex bone and joint infection |
| Ethics approval(s) | Committee for the Protection of Persons Sud Est III (CPP Sud Est III), ref: QH 20/2014 |
| Health condition(s) or problem(s) studied | 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 | |
| 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 study start date | 01/01/2011 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 43 |
| Key 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 |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- France
Study participating centre
France
Sponsor information
Hospital/treatment centre
Quai des Celestins
Lyon
69000
France
"ROR" |
https://ror.org/01502ca60 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 29/02/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/02/2016 | Yes | No |
Editorial Notes
18/02/2016: Publication reference added.
