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NCT04690569 · ClinicalTrials.gov registry record
Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)
A clinical trial, sponsored by MeMed Diagnostics.
- Completed
- Registry status
- 1,384
- Enrollment target
NCT04690569: Completed study, sponsored by MeMed Diagnostics.
NCT04690569 is a clinical trial that has completed, run by MeMed Diagnostics. The registered enrollment target is 1,384 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04690569 has completed, sponsored by MeMed Diagnostics.
- COMPLETED
- Registry status
- 1,384 participants
- Enrollment target
Study Summary
Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status. Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method. The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.
Primary Outcome
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
Interventions
- DIAGNOSTIC_TEST MeMed BV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,384 participants |
| Start Date | 2019-05-03 |
| Est. Completion | 2020-11-22 |
What the finished NCT04690569 record still lists
NCT04690569 is an observational study that tracks outcomes without assigning an intervention. Its 1,384 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which MeMed BV is the first listed.
NCT04690569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04690569 about?
NCT04690569 is a clinical study titled "Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)". Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each...
What is the current status of trial NCT04690569?
This trial is currently completed. The enrollment target is 1,384 participants. The study started on 2019-05-03. Estimated completion is 2020-11-22.
What interventions are being tested in trial NCT04690569?
The interventions under investigation include: MeMed BV (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04690569?
This trial is sponsored by MeMed Diagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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