Non-HIV Patients With Pneumocystis Jiroveci PneumoniaNCT02109887
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
An observational study of Non-HIV Patients With Pneumocystis Jiroveci Pneumonia, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Non-HIV Patients With Pneumocystis Jiroveci Pneumonia
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Non-HIV patients with PCP
Who may be able to join
- 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
Who cannot join
- HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Pneumocystis jiroveci, cytomegalovirus, co-infection
- Medical subject headings
- Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCP with true CMV co-infection | Not described | |
| PCP with innocent bystander CMV | Not described | |
| PCP without any evidence of CMV | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the diagnosis of PCP
Secondary outcomes (2)
overall mortality
Measured: 1 month after the diagnosis of PCP
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
Measured: 1 month after the diagnosis of PCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-HIV Patients With Pneumocystis Jiroveci PneumoniaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109887
- Sponsor's protocol ID
- S2013-1999-0005
- Other IDs
- 2014-0198
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
- ClinicalTrials.gov ID
- NCT02109887
- Acronym / sponsor ID
- S2013-1999-0005
- Keywords
- Pneumocystis jiroveci, cytomegalovirus, co-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCP with true CMV co-infection | – | – |
| PCP with innocent bystander CMV | – | – |
| PCP without any evidence of CMV | – | – |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-HIV patients with PCP
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
2 secondary outcomes
overall mortality
Time frame: 1 month after the diagnosis of PCP
innocent bystander CMV infection
Time frame: 1 month after the diagnosis of PCP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-HIV Patients With Pneumocystis Jiroveci Pneumonia, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV co-infection (time frame: 1 month after the diagnosis of PCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.