CMV InfectionCMV-RéaNCT02843880
Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study
An observational study of CMV Infection, run by AdministrateurDRC at 1 site in France.
Trial summary
Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to May 2016
- 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: Patients admitted in ICU for septic shock, without previous immunodepression, and who will stay in ICU for over 3 days, mechanically ventialted
Who may be able to join
- 18 years or older
- ICU admission for more than 3 days
- Admission for septic shock
- Patient with mechanical invasive ventilation
Who cannot join
- Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
- Seronegative patient for CMV
- Patient under anti-virus treatment
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Universitary Hospital - Medical Intensive Care Station
Grenoble, 38043
About this study
Official title: Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms.
In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.
Read the detailed description
Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.
A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.
- Conditions
- CMV Infection
- Keywords
- CMV reactivation, CMV disease, Predictive factors, Critically ill patients, Septic shock
- Medical subject headings
- Cytomegalovirus Infections, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock patients | Septic shock patients staying over 3 days mechanically ventilated in the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of CMV disease
CMV disease is defined by occurence of viremia and/or an organ failure
Measured: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)
Secondary outcomes (4)
Mortality
Measured: Day 28
Length of ICU stay
Measured: About 90 days
Duration of mechanical ventilation
Measured: About 90 days
Occurence of nosocomial infections
Measured: About 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startMar 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Problematic has become outdated in relation with current litterature advances.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurDRC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AdministrateurDRC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843880
- Sponsor's protocol ID
- 2012/130
- Acronym
- CMV-Réa
- Status last verified
- Jul 2016
- First submitted
- 23 Mar 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
- ClinicalTrials.gov ID
- NCT02843880
- Acronym / sponsor ID
- CMV-Réa / 2012/130
- Conditions
- CMV Infection
- Keywords
- CMV reactivation, CMV disease, Predictive factors, Critically ill patients, Septic shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problematic has become outdated in relation with current litterature advances.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AdministrateurDRCUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Jul 2016 (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.
Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms.
In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.
Detailed description
Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.
A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock patients | – | –Septic shock patients staying over 3 days mechanically ventilated in the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU for septic shock, without previous immunodepression, and who will stay in ICU for over 3 days, mechanically ventialted
Key inclusion criteria (4 listed)
- 18 years or older
- ICU admission for more than 3 days
- Admission for septic shock
- Patient with mechanical invasive ventilation
Key exclusion criteria (4 listed)
- Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
- Seronegative patient for CMV
- Patient under anti-virus treatment
- Patient under guardianship
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
Occurrence of CMV disease
Time frame: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)
CMV disease is defined by occurence of viremia and/or an organ failure
4 secondary outcomes
Mortality
Time frame: Day 28
Length of ICU stay
Time frame: About 90 days
Duration of mechanical ventilation
Time frame: About 90 days
Occurence of nosocomial infections
Time frame: About 90 days
Results and safety
The study was stopped early (reason given: Problematic has become outdated in relation with current litterature advances.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Infection, run by AdministrateurDRC 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 4 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: stopped early, as of the sponsor's last update on 26 Jul 2016. 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 was stopped early (reason given: Problematic has become outdated in relation with current litterature advances.). Results are not available in the source record.
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?
Occurrence of CMV disease (time frame: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)). 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 26 Jul 2016.