Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02109887
Enrollment
76
Registered
2014-04-10
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-HIV Patients With Pneumocystis Jiroveci Pneumonia

Keywords

Pneumocystis jiroveci, cytomegalovirus, co-infection

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.

Interventions

None listed

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CMV co-infection1 month after the diagnosis of PCPCMV co-infection is defined as (1) positive BAL (bronchoalveolar lavage fluid) CMV culture and (2) ganciclovir therapy for at least 1 week.

Secondary

MeasureTime frameDescription
overall mortality1 month after the diagnosis of PCP
innocent bystander CMV infection1 month after the diagnosis of PCPinnocent 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026