HIV InfectionsNCT05036928
Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
An observational study of HIV Infections and Sepsis, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
Sepsis is a common and critical complication in HIV-infected patients and an important marker of high risk of patient death. The widely used diagnostic criteria for sepsis still have many deficiencies and do not allow for good prediction and timely determination of the onset of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Sepsis
- What is being tested?
- Monocyte distribution width (MDW）
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to Oct 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients hospitalized in our hospital within 1 year since this study was conducted.
Who may be able to join
- Positive ELISA test results for HIV-1 antibodies;
- Hospitalized patients; Voluntarily signing the patient's informed consent and being able to promise to be followed up;
- No plans to move away from the current trial site during the course of the trial.
Who cannot join
- Western Blot and/or HIV RNA assay confirmed as HIV negative;
- Women who are pregnant or breastfeeding;
- Current drug users;
- Persons with a history of alcohol abuse that cannot be terminated;
- Persons of non-Chinese nationality;
- Other patients who, in the judgment of the investigator, are deemed unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Jun Chen, Ph.D, qtchenjun@163.com
About this study
Sepsis is a common and critical complication in HIV-infected patients and an important marker of high risk of patient death. The widely used diagnostic criteria for sepsis still have many deficiencies and do not allow for good prediction and timely determination of the onset of sepsis. In HIV-infected patients, abnormal activation of monocyte-macrophage is also a key mechanism in the development of their sepsis. Monocyte distribution width (MDW) is a marker of the degree of peripheral blood monocyte activation and has been recommended abroad for the early diagnosis of adult sepsis patients in emergency departments. However, in China, MDW has not been applied to the clinic yet, and the related studies are almost blank. Therefore, it is worthwhile to analyze the monocyte activation status of HIV-infected patients by MDW assay and thus predict the occurrence of sepsis.
Read the detailed description
This is a prospective observational study, and investigators intend to collect HIV-infected patients in our hospital within 1 year from the conduct of this study and hospitalized, after informed consent, for inclusion in the study. Investigators will collect clinical data, basic laboratory indicators, and test MDW levels of the patients and follow the patients until discharge or death.
- Conditions
- HIV Infections, Sepsis
- Being tested
- Monocyte distribution width (MDW）
- Medical subject headings
- HIV Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocyte distribution width (MDW）Diagnostic test
All enrolled patients will receive test with MDW.
| Study group | Role | What they receive |
|---|---|---|
| HIV infection group | Not described Receives: Diagnostic Test: Monocyte distribution width (MDW） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sepsis of admission
Using Sepsis 3.0 as the diagnostic criteria, the sensitivity and specificity of using MDW to diagnose sepsis in HIV-infected patients.
Measured: within 28 days
Number of deaths of enrolled patients
In HIV infection with sepsis, whether higher MDW score is related to poor prognosis.
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startDec 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Chen, MD, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036928
- Sponsor's protocol ID
- HIV-MDW
- Status last verified
- Nov 2021
- First submitted
- 3 Sep 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.
PubMed 31107278Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.
PubMed 32391157Agnello L, Bivona G, Vidali M, Scazzone C, Giglio RV, Iacolino G, Iacona A, Mancuso S, Ciaccio AM, Lo Sasso B, Ciaccio M. Monocyte distribution width (MDW) as a screening tool for sepsis in the Emergency Department. Clin Chem Lab Med. 2020 Oct 25;58(11):1951-1957. doi: 10.1515/cclm-2020-0417.
PubMed 32598299Moreira J, Paixao A, Oliveira J, Jalo W, Manuel O, Rodrigues R, Oliveira A, Tinoco L, Lima J, Grinsztejn B, Veloso VG, Japiassu AM, Lamas CC. Accuracy of quick sequential organ failure assessment score to predict mortality in hospitalized patients with suspected infection in an HIV/AIDS reference centre in Rio de Janeiro, Brazil. Clin Microbiol Infect. 2019 Jan;25(1):113.e1-113.e3. doi: 10.1016/j.cmi.2018.08.003. Epub 2018 Aug 15.
PubMed 30118761Sun J, Shao Y, Jiang R, Qi T, Xun J, Shen Y, Zhang R, Qian L, Wang X, Liu L, Wang Z, Sun J, Tang Y, Song W, Xu S, Yang J, Chen Y, Tang YW, Lu H, Chen J. Monocyte distribution width (MDW) as a reliable diagnostic biomarker for sepsis in patients with HIV. Emerg Microbes Infect. 2025 Dec;14(1):2479634. doi: 10.1080/22221751.2025.2479634. Epub 2025 Mar 26.
PubMed 40094401
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
- ClinicalTrials.gov ID
- NCT05036928
- Acronym / sponsor ID
- HIV-MDW
- Conditions
- HIV Infections, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Sep 2021 (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.
Sepsis is a common and critical complication in HIV-infected patients and an important marker of high risk of patient death. The widely used diagnostic criteria for sepsis still have many deficiencies and do not allow for good prediction and timely determination of the onset of sepsis. In HIV-infected patients, abnormal activation of monocyte-macrophage is also a key mechanism in the development of their sepsis. Monocyte distribution width (MDW) is a marker of the degree of peripheral blood monocyte activation and has been recommended abroad for the early diagnosis of adult sepsis patients in emergency departments. However, in China, MDW has not been applied to the clinic yet, and the related studies are almost blank. Therefore, it is worthwhile to analyze the monocyte activation status of HIV-infected patients by MDW assay and thus predict the occurrence of sepsis.
Detailed description
This is a prospective observational study, and investigators intend to collect HIV-infected patients in our hospital within 1 year from the conduct of this study and hospitalized, after informed consent, for inclusion in the study. Investigators will collect clinical data, basic laboratory indicators, and test MDW levels of the patients and follow the patients until discharge or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infection group | – | Diagnostic Test: Monocyte distribution width (MDW） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients hospitalized in our hospital within 1 year since this study was conducted.
Key inclusion criteria (3 listed)
- Positive ELISA test results for HIV-1 antibodies;
- Hospitalized patients; Voluntarily signing the patient's informed consent and being able to promise to be followed up;
- No plans to move away from the current trial site during the course of the trial.
Key exclusion criteria (6 listed)
- Western Blot and/or HIV RNA assay confirmed as HIV negative;
- Women who are pregnant or breastfeeding;
- Current drug users;
- Persons with a history of alcohol abuse that cannot be terminated;
- Persons of non-Chinese nationality;
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 |
|---|---|---|
| Monocyte distribution width (MDW）All enrolled patients will receive test with MDW. | Diagnostic test | HIV infection group |
Primary outcome
Number of participants with sepsis of admission
Time frame: within 28 days
Using Sepsis 3.0 as the diagnostic criteria, the sensitivity and specificity of using MDW to diagnose sepsis in HIV-infected patients.
Number of deaths of enrolled patients
Time frame: within 28 days
In HIV infection with sepsis, whether higher MDW score is related to poor prognosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 31107278Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.
- Background: PubMed 32391157Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.
- Background: PubMed 32598299Agnello L, Bivona G, Vidali M, Scazzone C, Giglio RV, Iacolino G, Iacona A, Mancuso S, Ciaccio AM, Lo Sasso B, Ciaccio M. Monocyte distribution width (MDW) as a screening tool for sepsis in the Emergency Department. Clin Chem Lab Med. 2020 Oct 25;58(11):1951-1957. doi: 10.1515/cclm-2020-0417.
- Background: PubMed 30118761Moreira J, Paixao A, Oliveira J, Jalo W, Manuel O, Rodrigues R, Oliveira A, Tinoco L, Lima J, Grinsztejn B, Veloso VG, Japiassu AM, Lamas CC. Accuracy of quick sequential organ failure assessment score to predict mortality in hospitalized patients with suspected infection in an HIV/AIDS reference centre in Rio de Janeiro, Brazil. Clin Microbiol Infect. 2019 Jan;25(1):113.e1-113.e3. doi: 10.1016/j.cmi.2018.08.003. Epub 2018 Aug 15.
- Derived from this study: PubMed 40094401Sun J, Shao Y, Jiang R, Qi T, Xun J, Shen Y, Zhang R, Qian L, Wang X, Liu L, Wang Z, Sun J, Tang Y, Song W, Xu S, Yang J, Chen Y, Tang YW, Lu H, Chen J. Monocyte distribution width (MDW) as a reliable diagnostic biomarker for sepsis in patients with HIV. Emerg Microbes Infect. 2025 Dec;14(1):2479634. doi: 10.1080/22221751.2025.2479634. Epub 2025 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
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 HIV Infections and Sepsis, run by Shanghai Public Health Clinical Center 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 3 inclusion and 6 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 30 Nov 2021. 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 Jun Chen, Ph.D (021-37990333-3222, qtchenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with sepsis of admission (time frame: within 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036928, which also lists 5 linked publications.
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 30 Nov 2021.