Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)

Conditions
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Non-HIV Patients With Pneumocystis Jiroveci Pneumonia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCP with true CMV co-infection<br> | |
| PCP with innocent bystander CMV<br> | |
| PCP without any evidence of CMV<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV co-infection | CMV co-infection is defined as (1) positive BAL (bronchoalveolar lavage fluid) CMV culture and (2) ganciclovir therapy for at least 1 week. | 1 month after the diagnosis of PCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mortality |  | 1 month after the diagnosis of PCP | 
| innocent bystander CMV infection | innocent bystander CMV infection positive blood CMV antigenemia and/or positive blood or BAL CMV qPCR without positive BAL CMV culture clinical improvement without ganciclovir therapy for at least 1 week | 1 month after the diagnosis of PCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumocystis jiroveci, cytomegalovirus, co-infection