Bone and Joint InfectionsDAPTO-HUSNCT01306825
Clinical Evaluation of Daptomycin Bone Penetration
An observational study of Bone and Joint Infections, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone and Joint Infections
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- May 2011to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -
Illkirch-Graffenstaden, 67400
Jeannot GAUDIAS, MD, 33 3 88 55 23 45, jeannot.gaudias@chru-strasbourg.fr
Jeannot GAUDIAS, MD
- Recruiting
Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé
Strasbourg, 67000
JEHL François, PHARM D, 33 3 68 85 37 81, francois.jehl@chru-strasbourg.fr
François JEHL, PARM D
- Recruiting
Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Nicolas Lefebvre, MD, 33 3 69 55 05 45, nicolas.lefebvre@chru-strasbourg.fr
Nicolas Lefebvre, MD
About this study
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.
- Conditions
- Bone and Joint Infections
- Keywords
- Daptomycin, Bone disease,infectious, Osteomyelitis, Diabetic foot, Staphylococcus aureus
- Medical subject headings
- Bone Diseases, Infectious, Osteomyelitis, Diabetic Foot, Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Lefebvre, MD, Study director, Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306825
- Sponsor's protocol ID
- 4683
- Acronym
- DAPTO-HUS
- Status last verified
- Mar 2015
- First submitted
- 25 Feb 2011
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Daptomycin Bone Penetration
- ClinicalTrials.gov ID
- NCT01306825
- Acronym / sponsor ID
- DAPTO-HUS / 4683
- Conditions
- Bone and Joint Infections
- Keywords
- Daptomycin, Bone disease,infectious, Osteomyelitis, Diabetic foot, Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Lefebvre, MD study director
Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infections, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Lefebvre, MD (33 3 69 55 05 45, nicolas.lefebvre@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.