Acute InfectionNCT05439551
Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)
An observational study of Acute Infection, run by MeMed Diagnostics Ltd. at 5 sites in 2 countries.
Trial summary
This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. Read more about this study
- Who is it for?
- Ages 90 days and older
- Conditions the study is for
- Acute Infection
- What is being tested?
- MeMed BV®
- How many people
- 215 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 11 Feb 2022to 29 Sep 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 90 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.
Who may be able to join
- Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements.
- Over 90 days of age.
- Clinical suspicion of acute bacterial or viral infection.
- Symptoms of acute infectious disease < 7 days.
- Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).
Who cannot join
- HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
- Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
- Pregnancy- self reported or medically confirmed.
- Active malignancy.
- Congenital or acquired immune deficiency (CID).
Show all 15Show fewer
- A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
- Significant trauma or burns in the last 7 days.
- Patients that have undergone major surgery in the last 7 days.
- Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
- Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days
- Monoclonal antibodies, anti-TNF agents
- Intravenous immunoglobulin (IVIG)
- Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
- G/GM-CSF, Interferons.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Israel3 sites
Hillel Yaffe Medical Center
Hadera
Carmel Medical Center
Haifa
Sourasky Medical Center - Ichilov
Tel Aviv
United States2 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Urgent Care Clinical Trials @ AFC Urgent Care- Easley
Easley, South Carolina, 29640
About this study
Official title: A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)
This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.
- Conditions
- Acute Infection
- Being tested
- MeMed BV®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMed BV®Diagnostic test
Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric and adults suspected of acute bacterial or viral infection | ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection. Receives: Diagnostic Test: MeMed BV® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start11 Feb 2022
- Primary completion13 Nov 2022
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439551
- Sponsor's protocol ID
- MMD012WB
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)
- ClinicalTrials.gov ID
- NCT05439551
- Acronym / sponsor ID
- MMD012WB
- Conditions
- Acute Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 30 Jun 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.
This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric and adults suspected of acute bacterial or viral infection | – | Diagnostic Test: MeMed BV®ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection. |
Who may qualify
- Ages
- 90 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.
Key inclusion criteria (5 listed)
- Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements.
- Over 90 days of age.
- Clinical suspicion of acute bacterial or viral infection.
- Symptoms of acute infectious disease < 7 days.
- Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).
Key exclusion criteria (15 listed)
- HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
- Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
- Pregnancy- self reported or medically confirmed.
- Active malignancy.
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 |
|---|---|---|
| MeMed BV®Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management. | Diagnostic test | Pediatric and adults suspected of acute bacterial or viral infection |
Primary outcome
Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices.
Time frame: Through study completion, an average of 18 months
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 24 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Infection, run by MeMed Diagnostics Ltd. at 5 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 5 inclusion and 15 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 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices. (time frame: Through study completion, an average of 18 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 24 Oct 2023.