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)

• Sponsor: MeMed Diagnostics Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05762302
• Collaborator: (none)
• Enrollment: 1,316
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 438.7
• Patients Per Site Per Month: 36.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Respiratory Tract Infection	Diagnostic Test: MeMed BV test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Masking Description: applicable only for control arm
• Primary Purpose: Diagnostic
• 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)
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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. [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219
2	Carmel Medical Center	Haifa		Israel
3	Sourasky Medical Center - Ichilov	Tel Aviv		Israel

Sponsors and Collaborators

• MeMed Diagnostics Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Measuring Outpatient Antibiotic Prescribin
• Antimicrobial resistance
• Tackling drug-resistant infections globally: final report and recommendations
• A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections

Publications

None provided.

• Responsible Party: MeMed Diagnostics Ltd.
• ClinicalTrials.gov Identifier: NCT05762302
• Other Study ID Numbers: MMD013RCT
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Emergencies

Study Results

No Results Posted as of Mar 9, 2023