Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2015 by University Hospital, Strasbourg, France
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01306825
First received: February 25, 2011
Last updated: June 17, 2015
Last verified: March 2015
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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:
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 ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306825
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | February 25, 2011 |
| Last Updated: | June 17, 2015 |
| Health Authority: | France: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on September 26, 2016