NCT01306825

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

March 1, 2015

Enrollment Period

4.5 years

First QC Date

February 25, 2011

Last Update Submit

June 17, 2015

Conditions

Bone and Joint Infections

Keywords

DaptomycinBone disease,infectiousOsteomyelitisDiabetic footStaphylococcus aureus

Outcome Measures

Primary Outcomes (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)

    5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients with deprived liberty
  • Inability to complete the informed consent process because of problems with mental capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -

Illkirch-Graffenstaden, 67400, France

RECRUITING

Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé

Strasbourg, 67000, France

RECRUITING

Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Bone Diseases, InfectiousOsteomyelitisDiabetic FootStaphylococcal Infections

Condition Hierarchy (Ancestors)

InfectionsBone DiseasesMusculoskeletal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Nicolas Lefebvre, MD

    Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Central Study Contacts

Nicolas Lefebvre, MD

CONTACT

33 3 69 55 05 45nicolas.lefebvre@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2011

First Posted

March 2, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-03

Locations

FR(3)