| NCT ID | NCT07211997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lumos Diagnostics |
| Condition | Acute Respiratory Infections (ARIs) |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-10-09 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent by parent/guardian and Assent for ages 7-11 years * Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F/38°C within 3 days (72 hours) of enrollment * Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath / difficulty breathing Exclusion Criteria: * Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized * Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral / inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy) * Taking antibiotics or antiviral therapy in the last 14 days * Received a live viral immunization in the last 14 days * Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment * Prior enrollment in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07211997 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 11 Years, studying Acute Respiratory Infections (ARIs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211997 currently recruiting?
Yes, NCT07211997 is actively recruiting participants. Contact the research team at Clinicalstudies@lumosdiagnostics.com for enrollment information.
Where is the NCT07211997 trial being conducted?
This trial is being conducted at Colton, United States, Clearwater, United States, Lutz, United States, Tampa, United States and 6 additional locations.
Who is sponsoring the NCT07211997 clinical trial?
NCT07211997 is sponsored by Lumos Diagnostics. The trial plans to enroll 800 participants.