Immunocompromised PatientsPCPNCT05605145
PCP in Immunocompromised Population in Southern China
An observational study of Immunocompromised Patients and Pneumocystis Pneumonia, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
To evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immunocompromised Patients, Pneumocystis Pneumonia, Diagnosis
- What is being tested?
- PCR was used to detect pneumocystis in respiratory specimens
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to 30 Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Immunocompromised patients who have fever, respiratory symptoms or pulmonary imaging changes were recruited into group.Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from enrolled patients and detected for pneumocystis by the combined detection system including qPCR and/or mNGS.
Who may be able to join
- Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease.
- Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
- Patients with radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
- Respiratory tract samples were collected for qPCR and/or mNGS detection.
Who cannot join
- Patients who were unable to obtain a respiratory specimen.
- Medical record was incomplete.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 510515
Cunwei Cao, MD, +86-13978608798, caocunwei@yeah.net
Meiqing Wu, MD, +86-15978184767, 453433378@qq.com
About this study
Official title: Pneumocystis Pneumonia in Immunocompromised Population in Southern China：A Multicenter,Open,Prospective Study
To evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.
Read the detailed description
Pneumocystis jirovecii pneumonia (PJP) is a serious opportunistic infection in immunocompromised patients, with a difficult diagnosis, rapid progression and high mortality rate. The PJP mortality rate is high among patients with delayed diagnosis and treatment, and death is due to severe respiratory failure. Up to now, data regarding Pneumocystis jirovecii infection in immunocompromised patients is limited. In the present prospective study, the investigators aimed to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.
- Being tested
- PCR was used to detect pneumocystis in respiratory specimens
- Keywords
- Pneumocystis Pneumonia, Immunocompromised Patients, Polymerase Chain Reaction, Treatment
- Medical subject headings
- Pneumonia, Pneumocystis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR was used to detect pneumocystis in respiratory specimensDiagnostic test
Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from all patients who met the enrollment conditions of this study. qPCR and/or mNGS were used to detect pneumocystis in respiratory specimens.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised patients | 1. Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease.
2. Typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
3. Radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
4. Respiratory tract samples were collected for qPCR and/or mNGS detection. Receives: Diagnostic Test: PCR was used to detect pneumocystis in respiratory specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
PJP diagnosis rate
Proven pneumocystis jirovecii pneumonia（PJP）was defined as direct microscopy positive finding of a bronchopulmonary specimen. The diagnosis of probable PJP was applied to patients with a positive qPCR or metagenomic Next-Generation Sequencing（mNGS）and several criteria including an underlying immunosuppressive condition, clinical symptoms and radiological signs deemed to be compatible with PJP by clinicians. Pneumocystis jirovecii colonization was defined as any case presented with a positive qPCR or mNGS, which was not included in the previous two groups. Non-PjP corresponded to a negative Pj result by the above detection method(direct microscopy,qPCR or mNGS).
Measured: 1 week
Secondary outcomes (2)
Treatment response rate of PJP
Treatment response was defined as one of the followings: (1)amelioration or resolution of baseline signs and symptoms, chest computed tomography (CT), and hospital discharge; (2)clinical improvement sustained at least 2 to 4 weeks after cessation of antifungal therapy.
Measured: 3 months
Overall Survival rate
Survival was defined as being alive 3 months after symptoms onset.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start12 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, The Fourth People's Hospital of Nanning, Chest Hospital of Guangxi Zhuang Autonomous Region, People's Hospital of Baise, LiuZhou People's Hospital, Nanning Second People's Hospital, The People's Hospital of Wuzhou, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Guangzhou Medical University, 923rd Hospital of the People's Liberation Army
- Responsible party
- Sponsor
- Investigators
- Cunwei Cao, MD, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605145
- Sponsor's protocol ID
- GX-PCP-2020
- Acronym
- PCP
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumocystis Pneumonia in Immunocompromised Population in Southern China：A Multicenter,Open,Prospective Study
- ClinicalTrials.gov ID
- NCT05605145
- Acronym / sponsor ID
- PCP / GX-PCP-2020
- Keywords
- Pneumocystis Pneumonia, Immunocompromised Patients, Polymerase Chain Reaction, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, The Fourth People's Hospital of Nanning, Chest Hospital of Guangxi Zhuang Autonomous Region, People's Hospital of Baise, LiuZhou People's Hospital, Nanning Second People's Hospital, The People's Hospital of Wuzhou, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Guangzhou Medical University, 923rd Hospital of the People's Liberation Army
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 Nov 2022 (actual)
- 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.
To evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.
Detailed description
Pneumocystis jirovecii pneumonia (PJP) is a serious opportunistic infection in immunocompromised patients, with a difficult diagnosis, rapid progression and high mortality rate. The PJP mortality rate is high among patients with delayed diagnosis and treatment, and death is due to severe respiratory failure. Up to now, data regarding Pneumocystis jirovecii infection in immunocompromised patients is limited. In the present prospective study, the investigators aimed to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in Southern China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised patients | – | Diagnostic Test: PCR was used to detect pneumocystis in respiratory specimens1. Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease. 2. Typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia. 3. Radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT). 4. Respiratory tract samples were collected for qPCR and/or mNGS detection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompromised patients who have fever, respiratory symptoms or pulmonary imaging changes were recruited into group.Respiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from enrolled patients and detected for pneumocystis by the combined detection system including qPCR and/or mNGS.
Key inclusion criteria (4 listed)
- Patients with immunocompromised conditions, including but not limited to HIV infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease.
- Patients with typical clinical manifestations of PJP such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia.
- Patients with radiological abnormalities suggestive to PJP in bilateral lungs revealed by chest computed tomography (CT).
- Respiratory tract samples were collected for qPCR and/or mNGS detection.
Key exclusion criteria (2 listed)
- Patients who were unable to obtain a respiratory specimen.
- Medical record was incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR was used to detect pneumocystis in respiratory specimensRespiratory tract specimens such as alveolar lavage fluid, sputum and throat swabs were collected from all patients who met the enrollment conditions of this study. qPCR and/or mNGS were used to detect pneumocystis in respiratory specimens. | Diagnostic test | Immunocompromised patients |
Primary outcome
PJP diagnosis rate
Time frame: 1 week
Proven pneumocystis jirovecii pneumonia（PJP）was defined as direct microscopy positive finding of a bronchopulmonary specimen. The diagnosis of probable PJP was applied to patients with a positive qPCR or metagenomic Next-Generation Sequencing（mNGS）and several criteria including an underlying immunosuppressive condition, clinical symptoms and radiological signs deemed to be compatible with PJP by clinicians. Pneumocystis jirovecii colonization was defined as any case presented with a positive qPCR or mNGS, which was not included in the previous two groups. Non-PjP corresponded to a negative Pj result by the above detection method(direct microscopy,qPCR or mNGS).
2 secondary outcomes
Treatment response rate of PJP
Time frame: 3 months
Overall Survival rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Cunwei Cao, MD principal investigator
First Affiliated Hospital of Guangxi Medical University
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 Immunocompromised Patients and Pneumocystis Pneumonia, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cunwei Cao, MD (+86-13978608798, caocunwei@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PJP diagnosis rate (time frame: 1 week). 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 4 Nov 2022.