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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN14244698 |
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Date of registration:
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28/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Daptomycin > 6 mg/kg/day in complex bone and joint infection
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Scientific title:
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Daptomycin > 6 mg/kg/day in complex bone and joint infection: prospective cohort study in a regional reference center |
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Date of first enrolment:
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01/01/2011 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14244698 |
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Study type:
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Observational |
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Study design:
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Cohort study (Treatment)
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Tristan
Ferry |
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Address:
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Service de Maladies Infectieuses
Hôpital de la Croix-Rousse
93 grande rue de la Croix-Rousse
69004
Lyon
France |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: N/A
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complex bone and joint infection
Infections and Infestations
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Occurence of serious adverse events
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Source(s) of Monetary Support
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Hospices Civils de Lyon
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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