Condition category
Infections and Infestations
Date applied
26/01/2016
Date assigned
28/01/2016
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Tristan Ferry

ORCID ID

Contact details

Service de Maladies Infectieuses
Hôpital de la Croix-Rousse
93 grande rue de la Croix-Rousse
Lyon
69004
France

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 measures

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

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

Sponsor information

Organisation

Hospices Civils de Lyon

Sponsor details

Quai des Celestins
Lyon
69000
France

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26888539

Publication citations

Additional files

Editorial Notes

18/02/2016: Publication reference added.