URIDxED: Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT02957136
• Collaborator: BioFire Diagnostics, LLC (Industry)
• Enrollment: 194
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Infections; Influenza, Human; Common Cold	Device: Rapid respiratory pathogen nucleic acid amplification test	N/A

Detailed Description

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample collection. Randomization is at the individual patient level. Intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. Control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary outcome is antibiotic administration or prescription during the initial ED episode of care. The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). The investigators secondary outcome is administration or prescription of antivirals during the initial ED episode of care. The investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
• Actual Study Start Date: Dec 8, 2016
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid respiratory pathogen test arm ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.	Device: Rapid respiratory pathogen nucleic acid amplification test; Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.
No Intervention: Usual care control arm ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED [Day 0]

Secondary Outcome Measures

1. Proportion of Patients With a Respiratory Pathogen Identified [Day 0]

   Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician

2. Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis [Day 0]

3. Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription [Day 0]

   Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients

4. Proportion of Patients Discharged Home From the ED Versus Hospital Admission [Day 0]

5. Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days [30 days]

6. Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) [Day 0]

7. Median Length of ED Stay [Day 0]

8. Median Length of Hospital Stay [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 101 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study

• English speaking or Spanish speaking patients

Exclusion Criteria:

• Neonates

• Prisoners

• Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator

• Non-English, non-Spanish speaking patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis
• BioFire Diagnostics, LLC

Investigators

• Principal Investigator: Christopher Polage, MD, MAS, Duke University
• Principal Investigator: Larissa May, MD, MSPH, University of California, Davis

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 23, 2018
• Informed Consent Form - Mar 23, 2018

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT02957136
• Other Study ID Numbers: 894097
• First Posted: Nov 6, 2016
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of California, Davis: Respiratory Tract Infections; Influenza, Human; Common Cold; Viral Infection; Pathology, Molecular; Molecular Diagnostics; Diagnostic Testing; Clinical Microbiology; Polymerase Chain Reaction; Antibiotic Stewardship; Antimicrobial Use; Emergency Department; Emergency Room
• Additional relevant MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Emergencies

Study Results

Participant Flow

Recruitment Details	Participants were recruited from rapid care and main adult and pediatric ED areas between December 2016 and April 2018.

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Period Title: Overall Study
STARTED	95	99
COMPLETED	93	98
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm	Total
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.	Total of all reporting groups
Overall Participants	93	98	191
Age, Customized (Count of Participants)
Pediatric (1-17 y)	32 34.4%	39 39.8%	71 37.2%
Adults (18 y or older)	61 65.6%	59 60.2%	120 62.8%
Sex: Female, Male (Count of Participants)
Female	55 59.1%	55 56.1%	110 57.6%
Male	38 40.9%	43 43.9%	81 42.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 29%	32 32.7%	59 30.9%
Not Hispanic or Latino	66 71%	66 67.3%	132 69.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	5 5.4%	1 1%	6 3.1%
Asian	3 3.2%	5 5.1%	8 4.2%
Native Hawaiian or Other Pacific Islander	2 2.2%	2 2%	4 2.1%
Black or African American	18 19.4%	17 17.3%	35 18.3%
White	43 46.2%	44 44.9%	87 45.5%
More than one race	20 21.5%	29 29.6%	49 25.7%
Unknown or Not Reported	2 2.2%	0 0%	2 1%
Region of Enrollment (participants) [Number]
United States	93 100%	98 100%	191 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Count of Participants [Participants]	20 21.5%	33 33.7%

2. Secondary Outcome

Title	Proportion of Patients With a Respiratory Pathogen Identified
Description	Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Count of Participants [Participants]	61 65.6%	20 20.4%

3. Secondary Outcome

Title	Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Count of Participants [Participants]	24 25.8%	8 8.2%

4. Secondary Outcome

Title	Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription
Description	Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Analysis limited to population receiving an Influenza test defining positive or negative laboratory confirmed Influenza status.

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	37
Count of Participants [Participants]	73 78.5%	32 32.7%

5. Secondary Outcome

Title	Proportion of Patients Discharged Home From the ED Versus Hospital Admission
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Count of Participants [Participants]	69 74.2%	66 67.3%

6. Secondary Outcome

Title	Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Count of Participants [Participants]	31 33.3%	38 38.8%

7. Secondary Outcome

Title	Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Analysis limited to patients with influenza test and positive influenza result.

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	24	8
Count of Participants [Participants]	7 7.5%	3 3.1%

8. Secondary Outcome

Title	Median Length of ED Stay
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	93	98
Median (Full Range) [hours]	4.7	5.0

9. Secondary Outcome

Title	Median Length of Hospital Stay
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid Respiratory Pathogen Test Arm	Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.	ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
Measure Participants	20	27
Median (Full Range) [hours]	71.2	54.93

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Collected all-cause mortality at 30 days, hospitalization (disposition from initial ED study visit), 30-day revisit to ED (all, respiratory illness-related, nonrespiratory illness related)
Arm/Group Title	Rapid Respiratory Pathogen Test Arm		Usual Care Control Arm
Arm/Group Description	ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.		ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
All Cause Mortality
	Rapid Respiratory Pathogen Test Arm		Usual Care Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/93 (1.1%)		0/98 (0%)
Serious Adverse Events
	Rapid Respiratory Pathogen Test Arm		Usual Care Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Rapid Respiratory Pathogen Test Arm		Usual Care Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.