ClinicalTrials.gg
CompletedNCT05439551Updated Oct 24, 2023

Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)

An observational study in Acute Infection, sponsored by MeMed Diagnostics Ltd.. Completed at 5 sites in 2 countries. Open to participants aged 90 Days and older. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by MeMed Diagnostics Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
215
Ages
90 Days and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Infection
03

In context

Lead sponsor

MeMed Diagnostics Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
90 Days and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written 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.
  2. Over 90 days of age.
  3. Clinical suspicion of acute bacterial or viral infection.
  4. Symptoms of acute infectious disease \< 7 days.
  5. Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).

Exclusion criteria

Exclusion Criteria:

  1. , , active , or active Tuberculosis infection (self-declared or known from medical records).
  2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
  3. Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
  4. Pregnancy- self reported or medically confirmed.
  5. Active .
  6. Congenital or acquired immune deficiency (CID).
  7. A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
  8. Significant trauma or burns in the last 7 days.
  9. Patients that have undergone major surgery in the last 7 days.
  10. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    1. Administration of P.O.\IV\IM high dose >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
    2. Monoclonal antibodies, anti-TNF agents
    3. Intravenous immunoglobulin (IVIG)
    4. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
    5. G/GM-CSF, Interferons.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
215 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: MeMed BV®

Interventions

  • Diagnostic testMeMed BV®

    Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

5 sites
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
  • Urgent Care Clinical Trials @ AFC Urgent Care- Easley
    Easley, South Carolina 29640, United States
  • Hillel Yaffe Medical Center
    Hadera, Israel
  • Carmel Medical Center
    Haifa, Israel
  • Sourasky Medical Center - Ichilov
    Tel Aviv, Israel
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Nov 2022, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2022
First posted
Jun 30, 2022
StartActual
Feb 11, 2022
Primary completionActual
Nov 13, 2022
CompletionActual
Sep 29, 2023
Last update
Oct 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05439551
Lead sponsor
MeMed Diagnostics Ltd.
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Feb 11, 2022
Primary completion
Nov 13, 2022
Completion
Sep 29, 2023
Last update
Oct 24, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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