Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01306825
First received: February 25, 2011
Last updated: August 24, 2011
Last verified: March 2011
  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: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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

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         
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         
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         
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

No publications provided

Responsible Party: Christine GEILLER, directeur de la Direction de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01306825     History of Changes
Other Study ID Numbers: 4683
Study First Received: February 25, 2011
Last Updated: August 24, 2011
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:
Arthritis, Infectious
Infection
Arthritis
Joint Diseases
Musculoskeletal Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014