Acute InfectionApolloNCT04690569
Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)
An observational study of Acute Infection, run by MeMed Diagnostics Ltd. at 11 sites in 2 countries.
Trial summary
Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Read more about this study
- Who is it for?
- Ages 90 days and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Infection
- What is being tested?
- MeMed BV
- How many people
- 1,384 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 3 May 2019to 22 Nov 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 90 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hospital admitted, ED and urgent care center patients over the age of 90 days, with suspected acute bacterial or viral infection and healthy subjects.
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 and assent from the patient (depending on the local requirements)
- Over 90 days of age
- Clinical suspicion of acute bacterial or viral infection
- Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days
- Current disease duration ≤ 7 days
Who cannot join
- Another unrelated episode of febrile infection within the past 2 weeks
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis
- >48 hours of oral antibiotic treatment
- >12 hours of intravenous\intramuscular antibiotic treatment
- HIV, HBV, or HCV infection (self-declared or known from medical records)
- A proven or suspected infection on presentation with Mycobacterial (e.g. Tuberculosis, MAC), parasitic or fungal (e.g. Candida, Histoplasma, Aspergillus) pathogen
Show all 27Show fewer
- Active inflammatory disease (e.g. IBD, SLE, JIA, RA, Kawasaki, other vasculitis)
- Major trauma and\or burns in the last 7 days
- Major surgery in the last 7 days
- Congenital immune deficiency (CID)
- Acquired immune deficiency\modulation state including:
- Active malignancy
- 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
- Post solid organ/bone marrow transplant patients
- Asplenia, sickle cell disease
- Indwelling central venous catheter
- Cystic Fibrosis
- Pregnancy- self reported or medically known
- Other severe illnesses that affect life expectancy and quality of life such as:
- Severe psychomotor retardation
- Congenital metabolic disorder
- End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Johns Hopkins
Baltimore, Maryland, 21218
Boston Children's Hospital
Boston, Massachusetts, 02115
American Family Care Urgent Care
Chattanooga, Tennessee, 37421
American Family Care Urgent Care
Easley, South Carolina, 29640
Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center
Houston, Texas, 77030
Maimonides Medical Center
New York, New York, 11219
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
American Family Care Urgent Care
Powdersville, South Carolina, 29611
Israel2 sites
Hillel Yaffe Medical Center
Hadera, 38100
Carmel Medical Center
Haifa, 3436212
About this study
Official title: Prospective, Multi-Center, Observational, Blinded Study to Establish the Diagnostic Performance of the MeMed BV™ Test for Differentiating Bacterial From Viral Infection in Patients With Suspected Acute Bacterial or Viral Infection ("APOLLO" STUDY)
Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status.
Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method.
The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.
- 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 BVDiagnostic test
The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.
| Study group | Role | What they receive |
|---|---|---|
| Infectious | Eligible pediatric and adult patients from ED\Urgent care and hospital admitted, with symptoms consistent with acute bacterial or viral infection. Receives: Diagnostic Test: MeMed BV | |
| Healthy | For the purpose of establishing a normal reference range. Receives: Diagnostic Test: MeMed BV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
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 Dec 2020
- Study start3 May 2019
- Primary completion22 Nov 2020
- Study completion22 Nov 2020
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
- 1,384 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
- NCT04690569
- Sponsor's protocol ID
- MMD010
- Acronym
- Apollo
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Observational, Blinded Study to Establish the Diagnostic Performance of the MeMed BV™ Test for Differentiating Bacterial From Viral Infection in Patients With Suspected Acute Bacterial or Viral Infection ("APOLLO" STUDY)
- ClinicalTrials.gov ID
- NCT04690569
- Acronym / sponsor ID
- Apollo / MMD010
- Conditions
- Acute Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,384 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 22 Nov 2020 (actual)
- Study completion
- 22 Nov 2020 (actual)
- First posted
- 30 Dec 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.
Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status.
Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method.
The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infectious | – | Diagnostic Test: MeMed BVEligible pediatric and adult patients from ED\Urgent care and hospital admitted, with symptoms consistent with acute bacterial or viral infection. |
| Healthy | – | Diagnostic Test: MeMed BVFor the purpose of establishing a normal reference range. |
Who may qualify
- Ages
- 90 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital admitted, ED and urgent care center patients over the age of 90 days, with suspected acute bacterial or viral infection and healthy subjects.
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 and assent from the patient (depending on the local requirements)
- Over 90 days of age
- Clinical suspicion of acute bacterial or viral infection
- Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days
- Current disease duration ≤ 7 days
Key exclusion criteria (27 listed)
- Another unrelated episode of febrile infection within the past 2 weeks
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis
- >48 hours of oral antibiotic treatment
- >12 hours of intravenous\intramuscular antibiotic treatment
- HIV, HBV, or HCV infection (self-declared or known from medical records)
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 BVThe MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only. | Diagnostic test | Healthy, Infectious |
Primary outcome
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
Time frame: Through study completion, an average of 18 months
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
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 5 Jan 2021.
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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.
11 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 11 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 27 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Israel. 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?
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method. (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 5 Jan 2021.