- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02109887
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
August 28, 2018 updated by: Sung-Han Kim, Asan Medical Center
PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in immunocompromised patients including HIV-infected patients, transplant recipients, and immunosuppressant users.
About one third of non-HIV patients with PCP have the evidence of co-infection with CMV.
In this difficult clinical situation, physicians have difficulty to decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.
However, there is no objective test to differentiate true co-infection of CMV from innocent bystander of CMV in those with PCP.
The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV from inocent bystander of CMV.
This findings may guide physicians to decide anti-CMV treatment in patients with PCP and CMV co-infection.
Study Overview
Status
Completed
Detailed Description
PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in immunocompromised patients including HIV-infected patients, transplant recipients, and immunosuppressant users.
About one third of non-HIV patients with PCP have the evidence of co-infection with CMV.
In this difficult clinical situation, physicians have difficulty to decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.
However, there is no objective test to differentiate true co-infection of CMV from innocent bystander of CMV in those with PCP.
The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV from inocent bystander of CMV.
This findings may guide physicians to decide anti-CMV treatment in patients with PCP and CMV co-infection.
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-HIV patients with PCP
Description
Inclusion Criteria:
- diagnosis of PCP based on PCP immunohistochemistry or PCP PCR
- age 16 or more
- agree with written informed consent
- WBC count 2000/uL or more
Exclusion Criteria:
- HIV infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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PCP with true CMV co-infection
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PCP with innocent bystander CMV
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PCP without any evidence of CMV
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CMV co-infection
Time Frame: 1 month after the diagnosis of PCP
|
CMV co-infection is defined as (1) positive BAL (bronchoalveolar lavage fluid) CMV culture and (2) ganciclovir therapy for at least 1 week.
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1 month after the diagnosis of PCP
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall mortality
Time Frame: 1 month after the diagnosis of PCP
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1 month after the diagnosis of PCP
|
|
innocent bystander CMV infection
Time Frame: 1 month after the diagnosis of PCP
|
innocent bystander CMV infection
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1 month after the diagnosis of PCP
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
March 31, 2014
First Submitted That Met QC Criteria
April 9, 2014
First Posted (Estimate)
April 10, 2014
Study Record Updates
Last Update Posted (Actual)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2013-1999-0005
- 2014-0198 (Other Identifier: Asan Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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