Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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