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Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01306825
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : March 2, 2011
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.

Condition or disease
Bone and Joint Infections

Study Design

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Evaluation of Daptomycin Bone Penetration
Study Start Date : May 2011
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Patients' percentage of which the intra-osseous daptomycin concentration is ≥ 8 times MIC (if available) or ≥ 8 times critical concentration (if Bacteriological documentation is unavailable) [ Time Frame: 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal
Criteria

Inclusion criteria:

  • Patient under treatment with daptomycin for more than 3 days with dosage at 6 mg/kg
  • Patient undergoing imperative surgery with bone withdrawal
  • Signed, and dated informed consent as defined by the Institutional Review Board
  • Male and female patients older than 18 years of age
  • Patients with social insurance
  • Patient with information on previous mandatory medical examination

Exclusion criteria :

  • Patient with no treatment by daptomycin or with a dosage < 6mg/kg or with less than 3 doses of daptomycine
  • Patient with no need for surgery
  • Patient younger than 18 years of age
  • Pregnant and nursing women
  • Patient refusal for inclusion
  • Patients with deprived liberty
  • Inability to complete the informed consent process because of problems with mental capacity
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306825


Contacts
Contact: Nicolas Lefebvre, MD 33 3 69 55 05 45 nicolas.lefebvre@chru-strasbourg.fr

Locations
France
Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann - Recruiting
Illkirch-Graffenstaden, France, 67400
Contact: Jeannot GAUDIAS, MD    33 3 88 55 23 45    jeannot.gaudias@chru-strasbourg.fr   
Principal Investigator: Jeannot GAUDIAS, MD         
Sub-Investigator: Cyril BOERI, MD         
Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé Recruiting
Strasbourg, France, 67000
Contact: JEHL François, PHARM D    33 3 68 85 37 81    francois.jehl@chru-strasbourg.fr   
Sub-Investigator: François JEHL, PARM D         
Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Nicolas Lefebvre, MD    33 3 69 55 05 45    nicolas.lefebvre@chru-strasbourg.fr   
Principal Investigator: Nicolas Lefebvre, MD         
Sub-Investigator: Daniel CHRISTMANN Daniel, MD, PhD         
Sub-Investigator: Yves HANSMANN, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Nicolas Lefebvre, MD Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01306825     History of Changes
Other Study ID Numbers: 4683
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Strasbourg, France:
Daptomycin
Bone disease,infectious
Osteomyelitis
Diabetic foot
Staphylococcus aureus

Additional relevant MeSH terms:
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents