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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMeMed Diagnostics Ltd.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Tactile fever or measured temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported), either of them noted at least once within the last 7 days.

Disqualifiers

Systemic antibiotics within 72 hours prior to enrollment

Inflammatory disease (e.g., IBD, SLE, Rheumatoid arthritis, 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MeMed BV test

    Diagnostic test

    Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition

Treatment groups

1,316 Participants
are divided into 2 treatment groups
Group A: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV armExperimental treatment 1 intervention
Group B: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.