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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 belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am suspected of or have been diagnosed with an infectious stomach/intestinal infection.
Select...
I have an inflammatory condition like IBD, lupus, or rheumatoid arthritis.
Select...
I have or might have an infection caused by bacteria like MAC, a parasite, or fungus such as Candida.
Select...
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
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
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Who is running the clinical trial?
MeMed Diagnostics Ltd.Lead Sponsor
16 Previous Clinical Trials
13,356 Total Patients Enrolled
4 Trials studying Bronchitis
3,561 Patients Enrolled for Bronchitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms like coughing or difficulty breathing, suggesting a lung infection.My doctor is considering prescribing me antibiotics.I have not taken antibiotics in the 3 days before my emergency or urgent care visit.You were born with a weakened immune system.I am suspected of or have been diagnosed with an infectious stomach/intestinal infection.My illness has been present for 7 days or less.I am 18 years old or older.You have had a fever of 100°F or higher at least once in the last 7 days.I have or might have an infection caused by bacteria like MAC, a parasite, or fungus such as Candida.You have had a serious injury or burns in the past week.I have been diagnosed with or treated for an active cancer in the last 6 months.I have an inflammatory condition like IBD, lupus, or rheumatoid arthritis.I have not had major surgery in the past week.I have taken immune-suppressive or immune-modulating therapies in the last 10 days.You have HIV, HBV, or HCV infection.You are pregnant, or you have been told by a doctor that you are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm
- Group 2: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.