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Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2015 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01306825

First Posted: March 2, 2011

Last Update Posted: June 18, 2015

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.

Information provided by (Responsible Party):

University Hospital, Strasbourg, France

Purpose

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
Bone and Joint Infections


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Clinical Evaluation of Daptomycin Bone Penetration

Resource links provided by NLM:

Drug Information available for: Daptomycin

Genetic and Rare Diseases Information Center resources: Osteomyelitis

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	15
Study Start Date:	May 2011
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Eligibility

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 Submitted:	February 25, 2011
First Posted:	March 2, 2011
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

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