Clinical trial NCT02109887: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
Official title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-HIV Patients With Pneumocystis Jiroveci Pneumonia
Keywords: Pneumocystis jiroveci, cytomegalovirus, co-infection
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-HIV patients with PCP

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CMV co-infection
timeFrame: 1 month after the diagnosis of PCP
Secondary outcomes:
measure: overall mortality
timeFrame: 1 month after the diagnosis of PCP
measure: innocent bystander CMV infection
timeFrame: 1 month after the diagnosis of PCP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: