TEM-PCR™ Prospective Clinical Utility Study

Upper Resp Tract Infection Clinical Trial

Official title: A Randomized, Open-label, Multi-Center, Prospective Study to Assess the Clinical Utility of TEM-PCR™ Upper Respiratory Panel in Adult Patients 65 and Older Presenting With Symptoms of Acute Respiratory Illness

Status Suspended

Clinical Trial Summary

This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR Upper Respiratory Infection (URI) Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness.

Clinical Trial Description

This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR URI Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness. The study will enroll 314 subjects with <10% of subjects having chronic conditions that may affect the lungs (i.e., CHF, COPD, and neoplastic disease of the lungs).

Subjects recruited from the general patient population visiting identified primary care clinic sites will be recruited and randomized to either TEM-PCR or Standard of Care (SOC)/empiric diagnosis for determination of respiratory pathogen(s). The treating physician will use the results of either the TEM-PCR panel or the SOC/empiric diagnosis to guide treatment decisions. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the TEM-PCR diagnosis will be available in approximately one business day of sample collection. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the SOC/empiric diagnosis will be available in approximately 3-5 business days of sample collection. The Investigator may call the subject upon receipt of sputum sample results if the results indicate that a change in therapy is necessary. All changes in the prescribed treatment plan will be documented in the subject's source documents. Subjects will record all therapy used for the treatment of respiratory illness and adverse events from Day 1 through Day 30 in a patient diary.

A final in-clinic visit will be conducted on Day 30 (± 5 days) following the Day 1 clinic visit to assess for outcomes (i.e., antibiotic treatment and duration/completion, use of antivirals and duration/completion, rate of clinic revisit or hospital admission and subsequent length of stay, mortality rate, use of steroids and/or antipyretics, use of OTC symptomatic treatments, and use of supportive therapy). ;

Related Conditions & MeSH terms

• Upper Resp Tract Infection

• NCT number: NCT04248361
• Study type: Interventional
• Source: Diatherix Laboratories, LLC
• Status: Suspended
• Phase: Phase 4
• Start date: March 6, 2020
• Completion date: May 31, 2022