A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Study Details
Study Description
Brief Summary
To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Detailed Description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Device Testing Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
Device: RPS Adeno Detector IV
One time test with the RPS Adeno Detector IV
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. [15 minutes]
Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
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Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:
I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)
II Signs: 1) presence of follicles, 2) presence of a preauricular node
III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation
Exclusion Criteria:
-
Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
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Patients with a corneal ulcer or history of recent trauma will also be excluded.
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Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
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Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Manatee Eye Clinic | Bradenton | Florida | United States | 34208 |
2 | Center For Excellence in Eye Care | Miami | Florida | United States | 33176 |
3 | St John's Clinic | Springfield | Missouri | United States | 65804 |
4 | Ophthalmic Consultants of Long Island | Lynbrook | New York | United States | 11563 |
5 | Weill-Cornell Medical College | New York | New York | United States | 10021 |
6 | South Shore Eye Care | Wantagh | New York | United States | 11793 |
7 | Wills Eye Institute | Philadelphia | Pennsylvania | United States | 19107 |
8 | Northeastern Eye Institute | Scranton | Pennsylvania | United States | 18503 |
Sponsors and Collaborators
- Rapid Pathogen Screening
Investigators
- Principal Investigator: Shachar Tauber, MD, St John's Clinic
- Principal Investigator: Jodi Luchs, MD, South Shore Eye Clinic
- Principal Investigator: William Trattler, MD, Center For Excellence In Eye Care
- Principal Investigator: Thomas Boland, MD, Northeastern Eye Institute
- Principal Investigator: Michael DellaVecchia, MD/PhD, Wills Eye Institute
- Principal Investigator: Murray Friedberg, MD, Manatee Eye Clinic
- Principal Investigator: Chris Starr, MD, Weill Medical College of Cornell University
- Principal Investigator: Marguerite McDonald, MD, Ophthalmic Consultants of Long Island
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 200-003
- NCT00799318
Study Results
Participant Flow
Recruitment Details | The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers. |
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Pre-assignment Detail |
Arm/Group Title | Device Testing |
---|---|
Arm/Group Description | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
Period Title: Overall Study | |
STARTED | 128 |
COMPLETED | 128 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Device Testing |
---|---|
Arm/Group Description | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
Overall Participants | 128 |
Age, Customized (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
43
|
Sex: Female, Male (Count of Participants) | |
Female |
76
59.4%
|
Male |
52
40.6%
|
Region of Enrollment (participants) [Number] | |
United States |
128
100%
|
Outcome Measures
Title | Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. |
---|---|
Description | Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture. |
Time Frame | 15 minutes |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | RPS Adeno Detector IV (Sensitivity) | RPS Adeno Detector IV (Specificity) |
---|---|---|
Arm/Group Description | Looking for the number of true positives as compared to cell culture. | Looking for the number of true negatives as compared to cell culture. |
Measure Participants | 31 | 97 |
Number (95% Confidence Interval) [percentage of cases] |
90
|
96
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Device Testing | |
Arm/Group Description | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV | |
All Cause Mortality |
||
Device Testing | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Device Testing | ||
Affected / at Risk (%) | # Events | |
Total | 0/128 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Device Testing | ||
Affected / at Risk (%) | # Events | |
Total | 0/128 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results to be published or presented shall be submitted to RPS for review and comment at least 30 days prior to submission for publication or presentation. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after RPS confirms there will be no multicenter study publication, whichever occurs first.
Results Point of Contact
Name/Title | Robert Sambusky, MD |
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Organization | Rapid Pathogen Screening, Inc. |
Phone | 941-556-1853 |
sambursky@rpsdetectors.com |
- 200-003
- NCT00799318