Upper Resp Tract InfectionPhase 4NCT04248361
TEM-PCR™ Prospective Clinical Utility Study
A Phase 4 study testing TEM-PCR URI Panel and SOC/Empiric Diagnosis in people with Upper Resp Tract Infection, run by Diatherix Laboratories, LLC at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Upper Resp Tract Infection
- What is being tested?
- TEM-PCR URI Panel and SOC/Empiric Diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Mar 2020to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provide written informed consent for the trial;
- Age 65 years or older;
- 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;
- Presentation with at least two of the following symptoms of acute respiratory illness:
- nasal congestion
- chest congestion
Show all 10Show fewer
- shortness of breath
- cough
- body ache
- fever (≥100.4 ºF)
Who cannot join
- Subject is currently taking antibiotics or has taken antibiotics within the previous 30 days.
- Subject is currently taking antivirals or has taken antivirals within the previous 30 days.
- Subject has been hospitalized within the previous 30 days.
- Severity of illness (according to the Investigator) requires immediate hospitalization or referral to specialty care.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Twilight Medical Center
Athens, Alabama, 35613
Valley Internal Medicine
Athens, Alabama, 35613
Blankenship Family Medicine
Huntsville, Alabama, 35801
Comprehensive Primary Care and Urgent Care of Alabama
Huntsville, Alabama, 35808
About this 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
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.
Read the 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
- Being tested
- TEM-PCR URI Panel, SOC/Empiric Diagnosis
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEM-PCR URI PanelDiagnostic 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 DiagnosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TEM-PCR Diagnosis | Experimental | 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. Receives: Diagnostic Test: TEM-PCR URI Panel |
| SOC/Empiric Diagnosis | Active comparator | 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. Receives: Other: SOC/Empiric Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with revisit to a healthcare facility
The rate of revisit to a healthcare facility (i.e., revisit to primary care, urgent care, or hospital ER) for the same reason (respiratory infection) as the initial visit between subjects assigned to SOC/empiric diagnosis and TEM-PCR diagnosis as well as in a subset of subjects with bacterial superinfection
Measured: 30 days
Secondary outcomes (15)
Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection
Measured: 30 days
Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis
Measured: 30 days
Total number of days of antibiotic use for respiratory infection during the follow-up period
Measured: 30 days
Appropriateness of initial antibiotic selection for respiratory infection
Appropriateness will be determined by the investigator based upon pathogen sensitivity to the initial antibiotic selection as determined by sputum culture results.
Measured: 30 days
Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1
Measured: 30 days
Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis
Measured: 30 days
Total number of days of antiviral use for respiratory infection during the follow-up period
Measured: 30 days
Appropriateness of initial antiviral selection for respiratory infection
Appropriateness will be determined by the investigator based upon pathogen sensitivity to the initial antiviral selection as determined by sputum culture results.
Measured: 30 days
Hospital admission for respiratory infection
The subject will be assessed as to whether or not they were admitted to a hospital during the time from the initial clinic visit until the final Day 30 clinic visit.
Measured: 30 days
Mortality from any cause within 30 days of Clinic visit
Measured: 30days
Clearance of respiratory infection at 30 days
The investigator will assess the patient via a directed physical exam to assess whether the patient's respiratory infection has resolved. This assessment will be conducted at the Day 30 visit.
Measured: 30 days
Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness
Measured: 30 days
Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness
Measured: 30 days
Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use)
Measured: 30 days
Length of hospital stay for respiratory infection
If a subject is admitted to the hospital for respiratory infection at any point from the initial clinic visit until the final Day 30 clinic visit, the length of the admission (in days) will be recorded.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start6 Mar 2020
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: Low enrollment due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Resp Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open-label, Multi-Center, Prospective Study
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diatherix Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Hassoun, MD, Principal investigator, Alabama Infectious Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248361
- Sponsor's protocol ID
- Diatherix-601
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04248361
- Acronym / sponsor ID
- Diatherix-601
- Conditions
- Upper Resp Tract Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Low enrollment due to COVID-19
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Diatherix Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-label, Multi-Center, Prospective Study
| Arm | Type | Receives |
|---|---|---|
| TEM-PCR Diagnosis | Experimental | Diagnostic Test: TEM-PCR URI PanelThe 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. |
| SOC/Empiric Diagnosis | Active comparator | Other: SOC/Empiric DiagnosisThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent for the trial;
- Age 65 years or older;
- 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;
- Presentation with at least two of the following symptoms of acute respiratory illness:
Key exclusion criteria (4 listed)
- Subject is currently taking antibiotics or has taken antibiotics within the previous 30 days.
- Subject is currently taking antivirals or has taken antivirals within the previous 30 days.
- Subject has been hospitalized within the previous 30 days.
- Severity of illness (according to the Investigator) requires immediate hospitalization or referral to specialty care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEM-PCR URI PanelTarget 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. | Diagnostic test | TEM-PCR Diagnosis |
| SOC/Empiric DiagnosisThe 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. | Other | SOC/Empiric Diagnosis |
Primary outcome
Proportion of subjects with revisit to a healthcare facility
Time frame: 30 days
The rate of revisit to a healthcare facility (i.e., revisit to primary care, urgent care, or hospital ER) for the same reason (respiratory infection) as the initial visit between subjects assigned to SOC/empiric diagnosis and TEM-PCR diagnosis as well as in a subset of subjects with bacterial superinfection
15 secondary outcomes
Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection
Time frame: 30 days
Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis
Time frame: 30 days
Total number of days of antibiotic use for respiratory infection during the follow-up period
Time frame: 30 days
Appropriateness of initial antibiotic selection for respiratory infection
Time frame: 30 days
Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1
Time frame: 30 days
Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis
Time frame: 30 days
Total number of days of antiviral use for respiratory infection during the follow-up period
Time frame: 30 days
Appropriateness of initial antiviral selection for respiratory infection
Time frame: 30 days
Hospital admission for respiratory infection
Time frame: 30 days
Mortality from any cause within 30 days of Clinic visit
Time frame: 30days
Clearance of respiratory infection at 30 days
Time frame: 30 days
Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness
Time frame: 30 days
Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness
Time frame: 30 days
Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use)
Time frame: 30 days
Length of hospital stay for respiratory infection
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Hassoun, MD principal investigator
Alabama Infectious Disease Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TEM-PCR URI Panel and SOC/Empiric Diagnosis in people with Upper Resp Tract Infection, run by Diatherix Laboratories, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with revisit to a healthcare facility (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.