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Diagnostic Test

MeMed BV Test for Respiratory Infection

N/A

Recruiting

Research Sponsored by MeMed Diagnostics Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis

Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a test can help clinicians decide whether to prescribe antibiotics to patients with LRTI. It aims to improve medical care and health outcomes.

Who is the study for?

Adults over 18 with symptoms of lower respiratory tract infections (LRTI) such as cough or chest discomfort, who haven't taken antibiotics in the last 72 hours. Participants must have a fever and be suspected to need antibiotics. Excluded are those with recent major trauma, active cancer, certain immune conditions, recent surgery, or known HIV/HBV/HCV.

What is being tested?

The trial is testing the MeMed BV test's effectiveness in guiding antibiotic use for patients with LRTI in emergency and urgent care settings. It aims to see if this can improve patient outcomes and reduce unnecessary antibiotic prescriptions.

What are the potential side effects?

Since the intervention is a diagnostic test rather than a medication or therapy, there are no direct side effects from the MeMed BV test itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am suspected of or have been diagnosed with an infectious stomach/intestinal infection.

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I have an inflammatory condition like IBD, lupus, or rheumatoid arthritis.

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I have or might have an infection caused by bacteria like MAC, a parasite, or fungus such as Candida.

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I have not had major surgery in the past week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV armExperimental Treatment1 Intervention

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

Group II: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control armActive Control1 Intervention

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

0 / 5Eligibility criteria met