Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)

June 17, 2015 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Illkirch-Graffenstaden, France, 67400
        • Recruiting
        • Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -
        • Contact:
      • Strasbourg, France, 67000
        • Recruiting
        • Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé
        • Contact:
        • Sub-Investigator:
          • François JEHL, PARM D
      • Strasbourg, France, 67091
        • Recruiting
        • Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Sub-Investigator:
          • Daniel CHRISTMANN Daniel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Nicolas Lefebvre, MD, Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

November 1, 2015

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (ESTIMATE)

March 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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