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

Completed

• Conditions: Non-HIV Patients With Pneumocystis Jiroveci Pneumonia

• Registration Number: NCT02109887
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-10
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV co-infection	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.

Secondary Outcome Measures

Name	Time	Method
innocent bystander CMV infection	1 month after the diagnosis of PCP	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
overall mortality	1 month after the diagnosis of PCP

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of