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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-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 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.
Sponsor: Asan Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • overall mortality [ Time Frame: 1 month after the diagnosis of PCP ]
  • innocent bystander CMV infection [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: March 31, 2014
Date Started: June 2014
Date Completion: December 2016
Last Updated: February 5, 2016
Last Verified: February 2016