InfectionNCT04448548
Possible Roles of MDW in Infection Management in Emergency Care
An observational study of Infection and Sepsis, run by Szeged University at 1 site in Hungary.
Trial summary
A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- blood sample taking
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2019to 31 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult (18+ years), receiving care for suspected infection
Who may be able to join
- adult (18+ years), receiving care for suspected infection
Who cannot join
- refuses to sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection.
Read the detailed description
MDW as a novel indicator can be useful in clinical practice in the emergency care. However, until now, no study has been published about MDW's general relationship and coherence with multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC) together.
- Being tested
- blood sample taking
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample takingOther
For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.
What is being measured
The primary outcome is the main question the study is designed to answer.
MDW cutoff value for infection
Cutoff value for MDW indicating infection
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Sep 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448548
- Sponsor's protocol ID
- MDW
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Roles of MDW in Infection Management in Emergency Care
- ClinicalTrials.gov ID
- NCT04448548
- Acronym / sponsor ID
- MDW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 26 Jun 2020 (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.
A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection.
Detailed description
MDW as a novel indicator can be useful in clinical practice in the emergency care. However, until now, no study has been published about MDW's general relationship and coherence with multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC) together.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (18+ years), receiving care for suspected infection
Key inclusion criteria (1 listed)
- adult (18+ years), receiving care for suspected infection
Key exclusion criteria (1 listed)
- refuses to sign the consent form
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 |
|---|---|---|
| blood sample takingFor study purposes, blood sample was taken during the first medical examination from patients with suspected infection. | Other | – |
Primary outcome
MDW cutoff value for infection
Time frame: 4 months
Cutoff value for MDW indicating infection
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 26 Jun 2020.
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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.
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 Infection and Sepsis, run by Szeged University at 1 site in Hungary.
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 1 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 26 Jun 2020. 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 Hungary. 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?
MDW cutoff value for infection (time frame: 4 months). 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 26 Jun 2020.