TEM-PCR™ Prospective Clinical Utility Study

NCT ID: NCT04248361

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2022-05-31

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).

Conditions

Upper Resp Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TEM-PCR Diagnosis

The TEM-PCR diagnostic technology will be used to assess for a source pathogen involved in the subject's acute respiratory illness. Results of the TEM-PCR URI Panel will be used by the physician to guide treatment decisions. If indicated, the investigator may also utilize rapid strep testing and rapid influenza testing for diagnosis. In the event a lower respiratory infection is suspected a chest x-ray or complete blood count (CBC) with differential may also be performed.

Group Type: EXPERIMENTAL

TEM-PCR URI Panel

Intervention Type: DIAGNOSTIC_TEST

Target Enriched Multiplex Polymerase Chain Reaction (TEM-PCR™) is a breakthrough molecular multiplex technology that allows rapid DNA/RNA identification of multiple pathogens (i.e., bacteria and viruses) in a single sample, typically within one day of specimen receipt.

SOC/Empiric Diagnosis

The Standard of Care for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.

Group Type: ACTIVE_COMPARATOR

SOC/Empiric Diagnosis

Intervention Type: OTHER

The SOC for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.

Interventions

TEM-PCR URI Panel

Target Enriched Multiplex Polymerase Chain Reaction (TEM-PCR™) is a breakthrough molecular multiplex technology that allows rapid DNA/RNA identification of multiple pathogens (i.e., bacteria and viruses) in a single sample, typically within one day of specimen receipt.

Intervention Type: DIAGNOSTIC_TEST

SOC/Empiric Diagnosis

The SOC for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diatherix Laboratories, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Hassoun, MD

Role: PRINCIPAL_INVESTIGATOR

Alabama Infectious Disease Center

Locations

Twilight Medical Center

Athens, Alabama, United States

Valley Internal Medicine

Athens, Alabama, United States

Blankenship Family Medicine

Huntsville, Alabama, United States

Comprehensive Primary Care and Urgent Care of Alabama

Huntsville, Alabama, United States

Countries

United States

Other Identifiers

Diatherix-601

Identifier Type: -

Identifier Source: org_study_id