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)

August 24, 2023 updated by: MeMed Diagnostics Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Sourasky Medical Center - Ichilov
        • Contact:
        • Principal Investigator:
          • David Zeltser, Prof.
    • North
      • Haifa, North, Israel
        • Recruiting
        • Carmel Medical Center
        • Principal Investigator:
          • Salim Halabi, Dr.
        • Contact:
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida-Jacksonville
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Chad Cannon, MD
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Principal Investigator:
          • Sergey Motov, Dr.
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Hospital
        • Principal Investigator:
          • Adam Singer, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia Thomas Jefferson Urgent Care
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University South Carolina
        • Contact:
        • Principal Investigator:
          • Gary Headden, MD
    • Texas
      • Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent must be obtained from the patient or his/her legal guardian.
  2. 18 years of age or older.
  3. Current disease duration ≤ 7 days.
  4. Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days.
  5. 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).
  6. Clinician consideration or intent to prescribe antibiotics.

Exclusion Criteria:

  1. Systemic antibiotics within 72 hours prior to ED/UCC presentation
  2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
  3. Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis)
  4. Congenital immune deficiency (CID)
  5. A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
  6. HIV, HBV, or HCV infection (self-declared or known from medical records)
  7. Major trauma and\or burns in the last 7 days
  8. Major surgery in the last 7 days
  9. Pregnancy- self reported or medically confirmed
  10. 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.
  11. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days
  12. Consider unsuitable for the study by the study team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm
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
Diagnostic test: MeMed BV test
Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
No Intervention: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, an average of 18 months
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).
Through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MeMed Diagnostics Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMD013RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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