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The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)

Primary Purpose

Lower Respiratory Tract Infection

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MeMed BV test
Sponsored by
MeMed Diagnostics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Respiratory Tract Infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent must be obtained from the patient or his/her legal guardian. 18 years of age or older. Current disease duration ≤ 7 days. Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days. Clinical suspicion of bacterial or viral LRTI: At least one of the following respiratory signs or symptoms: cough (new or worsening), sputum production, dyspnea, shortness of breath, chest discomfort, auscultatory abnormality (wheezing, rhonchi). Clinician consideration or intent to prescribe antibiotics. Exclusion Criteria: Systemic antibiotics within 72 hours prior to ED/UCC presentation Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis) Congenital immune deficiency (CID) A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen HIV, HBV, or HCV infection (self-declared or known from medical records) Major trauma and\or burns in the last 7 days Major surgery in the last 7 days Pregnancy- self reported or medically confirmed Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days Consider unsuitable for the study by the study team

Sites / Locations

  • University of Florida-JacksonvilleRecruiting
  • University of Kansas Medical CenterRecruiting
  • Maimonides Medical CenterRecruiting
  • Stony Brook University HospitalRecruiting
  • Philadelphia Thomas Jefferson Urgent CareRecruiting
  • Medical University South CarolinaRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Sourasky Medical Center - IchilovRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm

Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm

Arm Description

ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will not receive the BV result, and will treat according to standard of care. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Outcomes

Primary Outcome Measures

To demonstrate MeMed BV® added value on top of standard of care in lowering unwarranted antibiotic prescribing in patients with LRTI in the ED/UCC.
Primary outcome is total antibiotic prescription in the ED/UCC in the BV and control arms, defined as antibiotic initiation by the initial ED/UCC clinician (reached if the patient received antibiotics during ED/UCC visit).

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
August 24, 2023
Sponsor
MeMed Diagnostics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05762302
Brief Title
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Official Title
A Multicenter Randomized Controlled Trial to Establish the Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MeMed Diagnostics Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
applicable only for control arm
Allocation
Randomized
Enrollment
1316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm
Arm Type
Experimental
Arm Description
ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
Arm Title
Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm
Arm Type
No Intervention
Arm Description
ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will not receive the BV result, and will treat according to standard of care. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
Intervention Type
Diagnostic Test
Intervention Name(s)
MeMed BV test
Intervention Description
Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
Primary Outcome Measure Information:
Title
To demonstrate MeMed BV® added value on top of standard of care in lowering unwarranted antibiotic prescribing in patients with LRTI in the ED/UCC.
Description
Primary outcome is total antibiotic prescription in the ED/UCC in the BV and control arms, defined as antibiotic initiation by the initial ED/UCC clinician (reached if the patient received antibiotics during ED/UCC visit).
Time Frame
Through study completion, an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent must be obtained from the patient or his/her legal guardian. 18 years of age or older. Current disease duration ≤ 7 days. Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days. Clinical suspicion of bacterial or viral LRTI: At least one of the following respiratory signs or symptoms: cough (new or worsening), sputum production, dyspnea, shortness of breath, chest discomfort, auscultatory abnormality (wheezing, rhonchi). Clinician consideration or intent to prescribe antibiotics. Exclusion Criteria: Systemic antibiotics within 72 hours prior to ED/UCC presentation Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis) Congenital immune deficiency (CID) A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen HIV, HBV, or HCV infection (self-declared or known from medical records) Major trauma and\or burns in the last 7 days Major surgery in the last 7 days Pregnancy- self reported or medically confirmed Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days Consider unsuitable for the study by the study team
Facility Information:
Facility Name
University of Florida-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Munson
Phone
904-244-8605
Email
Taylor.Munson@jax.ufl.edu
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Lemar
Phone
913-588-3580
Email
llemar@kumc.edu
First Name & Middle Initial & Last Name & Degree
Chad Cannon, MD
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Motov, Dr.
Phone
718-283-7212
Email
smotov@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Sergey Motov, Dr.
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Taylor
Phone
631-444-8345
Email
Maria.Taylor@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Adam Singer, MD
Facility Name
Philadelphia Thomas Jefferson Urgent Care
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Renzi
Phone
215-955-2471
Email
nicole.renzi@jefferson.edu
Facility Name
Medical University South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amihya Brock
Phone
843-792-7944
Email
brockami@musc.edu
First Name & Middle Initial & Last Name & Degree
Gary Headden, MD
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Martin
Phone
214-648-2147
Email
Riley.Martin@UTSouthwestern.edu
Facility Name
Carmel Medical Center
City
Haifa
State/Province
North
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salim Halabi, Dr.
Phone
048250655
Email
SalimHa@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Salim Halabi, Dr.
Facility Name
Sourasky Medical Center - Ichilov
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zeltser, Prof.
Phone
03-6973776
Email
davidz@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
David Zeltser, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.cdc.gov/antibiotic-use/data/outpatient-prescribing/index.html
Description
Measuring Outpatient Antibiotic Prescribin
URL
https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
Description
Antimicrobial resistance
URL
https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf
Description
Tackling drug-resistant infections globally: final report and recommendations
URL
https://www.nature.com/articles/s41467-020-14975-w
Description
A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections

Learn more about this trial

The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)

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