Cytomegalovirus Infection2006/25NCT00699868
Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients
A study testing Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings in people with Cytomegalovirus Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Aug 2011
- Phase
- Interventional
- 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
- Age more than 18-year-old
- Informed consent
Who cannot join
- minors,
- pregnant or lactating women,
- adults under guardianship,
- immunosuppression at the entrance to resuscitation,
- AIDS
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de Sainte Marguerite- Service de Réanimation Médicale
Marseille, 13009
About this study
Official title: Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients
This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.
Read the detailed description
Candidates will be screened with medical history and blood tests.Then, 2 groups of 20 patients (with or without CMV reactivation) matched for CMV status will be compared for their immune system against CMV.
- Conditions
- Cytomegalovirus Infection
- Being tested
- Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsOther
Sampling of blood
Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsOther
Sampling of blood
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Infection to CMV Receives: Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings |
| 2 | Other | Group "control CMV" Receives: Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV
Measured: 24 months
Secondary outcomes (1)
Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Marie FOREL, MD, Principal investigator, Assistance Publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699868
- Sponsor's protocol ID
- 2007-A01197-46
- Acronym
- 2006/25
- Status last verified
- Jun 2012
- First submitted
- 13 Jun 2008
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Matta J, Baratin M, Chiche L, Forel JM, Cognet C, Thomas G, Farnarier C, Piperoglou C, Papazian L, Chaussabel D, Ugolini S, Vely F, Vivier E. Induction of B7-H6, a ligand for the natural killer cell-activating receptor NKp30, in inflammatory conditions. Blood. 2013 Jul 18;122(3):394-404. doi: 10.1182/blood-2013-01-481705. Epub 2013 May 17.
PubMed 23687088Forel JM, Chiche L, Thomas G, Mancini J, Farnarier C, Cognet C, Guervilly C, Daumas A, Vely F, Xeridat F, Vivier E, Papazian L. Phenotype and functions of natural killer cells in critically-ill septic patients. PLoS One. 2012;7(12):e50446. doi: 10.1371/journal.pone.0050446. Epub 2012 Dec 6.
PubMed 23236375
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients
- ClinicalTrials.gov ID
- NCT00699868
- Acronym / sponsor ID
- 2006/25 / 2007-A01197-46
- Conditions
- Cytomegalovirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Jun 2008 (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.
This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.
Detailed description
Candidates will be screened with medical history and blood tests.Then, 2 groups of 20 patients (with or without CMV reactivation) matched for CMV status will be compared for their immune system against CMV.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsInfection to CMV |
| 2 | Other | Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsGroup "control CMV" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18-year-old
- Informed consent
Key exclusion criteria (5 listed)
- minors,
- pregnant or lactating women,
- adults under guardianship,
- immunosuppression at the entrance to resuscitation,
- AIDS
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 |
|---|---|---|
| Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsSampling of blood | Other | 1 |
| Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markingsSampling of blood | Other | 2 |
Primary outcome
Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV
Time frame: 24 months
1 secondary outcome
Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- Derived from this study: PubMed 23687088Matta J, Baratin M, Chiche L, Forel JM, Cognet C, Thomas G, Farnarier C, Piperoglou C, Papazian L, Chaussabel D, Ugolini S, Vely F, Vivier E. Induction of B7-H6, a ligand for the natural killer cell-activating receptor NKp30, in inflammatory conditions. Blood. 2013 Jul 18;122(3):394-404. doi: 10.1182/blood-2013-01-481705. Epub 2013 May 17.
- Derived from this study: PubMed 23236375Forel JM, Chiche L, Thomas G, Mancini J, Farnarier C, Cognet C, Guervilly C, Daumas A, Vely F, Xeridat F, Vivier E, Papazian L. Phenotype and functions of natural killer cells in critically-ill septic patients. PLoS One. 2012;7(12):e50446. doi: 10.1371/journal.pone.0050446. Epub 2012 Dec 6.
Related trials for Cytomegalovirus Infection
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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-Marie FOREL, MD principal investigator
Assistance Publique des Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings in people with Cytomegalovirus Infection, run by Assistance Publique Hopitaux De Marseille at 1 site 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 5 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: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699868, which also lists 2 linked publications.
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 4 Jun 2012.