Spine InfectionPhase 3NCT00372281
Cliavist in Infectious and Degenerative Diseases of the Spine
A Phase 3 study testing Cliavist in people with Spine Infection, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Infection
- What is being tested?
- Cliavist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2007to Dec 2009
- Phase
- Phase 3
- 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
Who may be able to join
- spine infection or spine degenerative disease
- patient agreement obtained
Who cannot join
- pregnancy
- MRI contra-indications
- cliavist contra-indication
- dextran allergy
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Not yet recruiting
Service de Neuroradiologie - Hôpital Central
Nancy, 54035
Serge Bracard, MD, s.bracard@chu-nancy.fr
Emmanuelle Schmitt, MD, e.schmitt@chu-nancy.fr
- Not yet recruiting
Nouvel Hôpital Civil
Strasbourg, 67091
Guillaume BIERRY, MD, 33 (3) 88116280, guillaume.bierry@chru-strasbourg.fr
Guillaume BIERRY, MD
- Recruiting
Service de Radiologie 2 - Hôpital de Hautepierre
Strasbourg, 67098
Jean-louis Dietemann, MD, jean-louis.dietemann@chru-strasbourg.fr
Stephane Kremer, MD, stephane.kremer@chru-strasbourg.fr
- Not yet recruiting
Service de Rhumatologie - Hôpital de Hautepierre
Strasbourg, 67098
Jean Sibilia, MD, jean.sibilia@chru-strasbourg.fr
Jean Sibilia, MD
About this study
Official title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.
- Conditions
- Spine Infection
- Being tested
- Cliavist
- Keywords
- MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliavistDrug
Injection of 0,9 mL (weight < 60kg) or 1,4 mL (weight > 60kg) of Cliavist (ferucarbotran) by direct intraveinous way, 48 h following the MRI done with gadolinium.
| Study group | Role | What they receive |
|---|---|---|
| Cliavist | Experimental | Not described Receives: Drug: Cliavist |
What is being measured
The primary outcome is the main question the study is designed to answer.
First MRI: performed immediately after gadolinium administration
Measured: immediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration
Measured: 24 hours after cliavist administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startMar 2007
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Louis Dietemann, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372281
- Sponsor's protocol ID
- 3780
- Status last verified
- Feb 2009
- First submitted
- 4 Sep 2006
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
- ClinicalTrials.gov ID
- NCT00372281
- Acronym / sponsor ID
- 3780
- Conditions
- Spine Infection
- Keywords
- MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Sep 2006 (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.
USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cliavist | Experimental | Drug: Cliavist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spine infection or spine degenerative disease
- patient agreement obtained
Key exclusion criteria (4 listed)
- pregnancy
- MRI contra-indications
- cliavist contra-indication
- dextran allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliavistInjection of 0,9 mL (weight < 60kg) or 1,4 mL (weight > 60kg) of Cliavist (ferucarbotran) by direct intraveinous way, 48 h following the MRI done with gadolinium. | Drug | Cliavist |
Primary outcome
First MRI: performed immediately after gadolinium administration
Time frame: immediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration
Time frame: 24 hours after cliavist administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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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.
Jean-Louis Dietemann, MD study director
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cliavist in people with Spine Infection, run by University Hospital, Strasbourg, France at 4 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 2 inclusion and 4 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 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jean-Louis Dietemann, MD ((33) 3 88127888, jean-louis.dietemann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First MRI: performed immediately after gadolinium administration (time frame: immediately after gadolinium administration). The study lists 2 primary outcomes in all. 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 25 Feb 2009.