Clinical trial NCT04248361: TEM-PCR™ Prospective Clinical Utility Study
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Upper Resp Tract Infection
Lead sponsor: Diatherix Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 314
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Open-label, Multi-Center, Prospective Study
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent for the trial;
2. Age 65 years or older;
3. In the opinion of the investigator, subject has the cognitive ability to provide accurate information to study site personnel and to follow instructions, or subject has a caregiver who can provide accurate information and ensure subject's compliance with instructions;
4. Presentation with at least two of the following symptoms of acute respiratory illness:

   1. nasal congestion
   2. chest congestion
   3. shortness of breath
   4. cough
   5. body ache
   6. fever (≥100.4 ºF)

Exclusion Criteria:

1. Subject is currently taking antibiotics or has taken antibiotics within the previous 30 days.
2. Subject is currently taking antivirals or has taken antivirals within the previous 30 days.
3. Subject has been hospitalized within the previous 30 days.
4. Severity of illness (according to the Investigator) requires immediate hospitalization or referral to specialty care.

Primary outcomes:
measure: Proportion of subjects with revisit to a healthcare facility
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection
timeFrame: 30 days
measure: Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis
timeFrame: 30 days
measure: Total number of days of antibiotic use for respiratory infection during the follow-up period
timeFrame: 30 days
measure: Appropriateness of initial antibiotic selection for respiratory infection
timeFrame: 30 days
measure: Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1
timeFrame: 30 days
measure: Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis
timeFrame: 30 days
measure: Total number of days of antiviral use for respiratory infection during the follow-up period
timeFrame: 30 days
measure: Appropriateness of initial antiviral selection for respiratory infection
timeFrame: 30 days
measure: Hospital admission for respiratory infection
timeFrame: 30 days
measure: Mortality from any cause within 30 days of Clinic visit
timeFrame: 30days
measure: Clearance of respiratory infection at 30 days
timeFrame: 30 days
measure: Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness
timeFrame: 30 days
measure: Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness
timeFrame: 30 days
measure: Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use)
timeFrame: 30 days
measure: Length of hospital stay for respiratory infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: United States
facility: Twilight Medical Center
state: Alabama
city: Athens
country: United States
facility: Valley Internal Medicine
state: Alabama
city: Huntsville
country: United States
facility: Blankenship Family Medicine
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Primary Care and Urgent Care of Alabama
state: Alabama
Study officials:
affiliation: Alabama Infectious Disease Center
name: Ali Hassoun, MD
role: PRINCIPAL_INVESTIGATOR
References: