Clinical Evaluation of Daptomycin Bone Penetration (NCT01306825) | Clinical Trial Compass
UnknownNot Applicable
Clinical Evaluation of Daptomycin Bone Penetration
France15 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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)
Timeframe: 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin