SepsisNCT06665542
A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
An observational study of Sepsis and Acute Infection, run by MeMed Diagnostics Ltd. at 8 sites in 2 countries.
Trial summary
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years. The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Acute Infection
- How many people
- 2,000 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 12 Nov 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients presenting with suspected infection/sepsis as defined by the attending physician, based on clinical presentation and laboratory/radiological findings. Additionally, the study will recruit healthy individuals across all study sites.
Who may be able to join
None listed.
Who cannot join
- Suspected acute infection/sepsis patients
- Patients fulfilling the following criteria are not eligible for inclusion in this study:
- HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
- Pregnancy- self reported or medically confirmed. Healthy individuals
- Patients fulfilling the following criteria are not eligible for inclusion in this study:
- Episode of infection in the last 2 weeks
Show all 10Show fewer
- Major trauma and\or burns and\or surgery in the last 2 weeks
- HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records)
- Elective surgery patients
- Pregnancy- self reported or medically confirmed
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Israel6 sites
Carmel MC
Haifa, 3436212
Rambam MC
Haifa, 3902908
Edith Wolfson MC
Holon, 2240832
Shaare Zedek MC
Jerusalem, 93722
Beilinson MC
Petah Tikva, 4649275
Sheba Tel-HaShomer MC
Tel Aviv, 52621
United States2 sites
MCW
Milwaukee, Wisconsin, 53226
Maimonides MC
New York, New York, 11219
About this study
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
Read the detailed description
For determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy").
Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment.
In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission.
Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.
- Conditions
- Sepsis, Acute Infection
- Keywords
- Host response, Suspected sepsis, Suspected acute infection, Biomarkers, ARDS, Septic shock, Sepsis associated AKI
- Medical subject headings
- Sepsis, Shock, Septic
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 |
|---|---|---|
| Suspected infection/sepsis | Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation. | |
| Healthy Individuals | No clinical suspicion of acute infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis.
Measured: 3,14 and 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start12 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665542
- Sponsor's protocol ID
- MMD01SEV
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
- ClinicalTrials.gov ID
- NCT06665542
- Acronym / sponsor ID
- MMD01SEV
- Conditions
- Sepsis, Acute Infection
- Keywords
- Host response, Suspected sepsis, Suspected acute infection, Biomarkers, ARDS, Septic shock, Sepsis associated AKI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Oct 2024 (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.
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
Detailed description
For determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy").
Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment.
In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission.
Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected infection/sepsis | – | –Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation. |
| Healthy Individuals | – | –No clinical suspicion of acute infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting with suspected infection/sepsis as defined by the attending physician, based on clinical presentation and laboratory/radiological findings. Additionally, the study will recruit healthy individuals across all study sites.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Suspected acute infection/sepsis patients
- HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
- Pregnancy- self reported or medically confirmed. Healthy individuals
- Episode of infection in the last 2 weeks
- Major trauma and\or burns and\or surgery in the last 2 weeks
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
Primary objective
Time frame: 3,14 and 28 Days
To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Infection, run by MeMed Diagnostics Ltd. at 8 sites in 2 countries.
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 0 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary objective (time frame: 3,14 and 28 Days). 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 30 Oct 2024.