Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)
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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
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Condition or disease |
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Bone and Joint Infections |
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 |

- 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 ]

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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 |
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

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
Contact: Nicolas Lefebvre, MD | 33 3 69 55 05 45 | nicolas.lefebvre@chru-strasbourg.fr |
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 |
Study Director: | Nicolas Lefebvre, MD | Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg |
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 |