Clinical Evaluation of Daptomycin Bone Penetration

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01306825

Acronym

DAPTO-HUS

Enrollment

Registered

2011-03-02

Start date

2011-05-31

Completion date

2015-11-30

Last updated

2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and Joint Infections

Keywords

Daptomycin, Bone disease,infectious, Osteomyelitis, Diabetic foot, Staphylococcus aureus

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactNicolas Lefebvre, MD

nicolas.lefebvre@chru-strasbourg.fr33 3 69 55 05 45

Outcome results