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Not Yet Recruiting NCT05762302

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)

Conditions: Lower Respiratory Tract Infection

Sex: All
Ages: 18 Years – 99 Years
Phase: NA
Enrollment: 1316
Sponsor: MeMed Diagnostics Ltd.

Location: United States

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.

Eligibility Criteria

Inclusion Criteria: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.Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days.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).Clinician consideration or intent to prescribe antibiotics.Exclusion Criteria:Systemic antibiotics within 72 hours prior to ED/UCC presentationSuspicion and/or confirmed diagnosis of infectious gastroenteritis/colitisInflammatory disease (e.g., IBD, SLE, RA, 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) pathogenHIV, HBV, or HCV infection (self-declared or known from medical records)Major trauma and\or burns in the last 7 daysMajor surgery in the last 7 daysPregnancy- self reported or medically confirmedActive 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.Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 daysConsider unsuitable for the study by the study team

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05762302). StuddyBuddy aggregates publicly available trial information.