CMV InfectionNCT02324244
CMV Intensive Care Units
An observational study of CMV Infection, run by Emilio Bouza at 1 site in Spain.
Trial summary
Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to May 2013
- 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: immunocompetent adults admitted to a major heart surgery intensive care unit
Who may be able to join
- Agreeing to participate in the study
- Age of at least 18 years
- Admission to the MHS-ICU for at least 72 hours
Who cannot join
- Inability to give informed consent
- Age younger than 18 years
- AIDS
- Pregnancy
- Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Microbiologia y Enfermedades Infecciosas
Madrid, Madrid, 28007
About this study
Official title: A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients
Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.
- Conditions
- CMV Infection
- Keywords
- Cytomegalovirus, critical patient, ICU, immunocompetent, clinical suspicion, risk factors
- Medical subject headings
- Cytomegalovirus Infections
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 |
|---|---|---|
| immunocompetent patients underwent heart surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence number of participants with a positive CMV positive result
Measured: month 8
Secondary outcomes (3)
risk factors for CMV reactivation
Measured: month 8
mortality by day 30
composite endpoint. hospitalization or death by day 30
Measured: month 8
prolonged hospitalization . More than 30 days
Measured: month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilio Bouza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emilio Bouza, Hospital General Universitario Gregorio Marañon
- Investigators
- Patricia Muñoz, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324244
- Sponsor's protocol ID
- MICRO.HGUGM.2014-006
- Status last verified
- Dec 2014
- First submitted
- 26 Nov 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients
- ClinicalTrials.gov ID
- NCT02324244
- Acronym / sponsor ID
- MICRO.HGUGM.2014-006
- Conditions
- CMV Infection
- Keywords
- Cytomegalovirus, critical patient, ICU, immunocompetent, clinical suspicion, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Emilio BouzaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Dec 2014 (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.
Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immunocompetent patients underwent heart surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- immunocompetent adults admitted to a major heart surgery intensive care unit
Key inclusion criteria (3 listed)
- Agreeing to participate in the study
- Age of at least 18 years
- Admission to the MHS-ICU for at least 72 hours
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Age younger than 18 years
- AIDS
- Pregnancy
- Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy
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
incidence number of participants with a positive CMV positive result
Time frame: month 8
3 secondary outcomes
risk factors for CMV reactivation
Time frame: month 8
mortality by day 30
Time frame: month 8
prolonged hospitalization . More than 30 days
Time frame: month 8
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 24 Dec 2014.
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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.
Patricia Muñoz, PhD principal investigator
Hospital General Universitario Gregorio Marañon
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 Emilio Bouza at 1 site in Spain.
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 3 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 24 Dec 2014. 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 Spain. 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?
incidence number of participants with a positive CMV positive result (time frame: month 8). 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 24 Dec 2014; AzTrials last refreshed its copy on 2 Nov 2026.