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

Non-HIV Patients With Pneumocystis Jiroveci Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109887
• Other study ID #: S2013-1999-0005
• Secondary ID: 2014-0198
• Status: Completed
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coinfection
• Infection
• Non-HIV Patients With Pneumocystis Jiroveci Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall mortality		1 month after the diagnosis of PCP
Secondary	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