A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
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Purpose
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 | Intervention |
|---|---|
|
Conjunctivitis |
Device: RPS Adeno Detector IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture. |
- Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.
| Enrollment: | 128 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: RPS Adeno Detector IV
|
Detailed Description:
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- 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.
- Patients with a corneal ulcer or history of recent trauma will also be excluded.
- Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
- 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| United States, Florida | |
| Manatee Eye Clinic | |
| Bradenton, Florida, United States, 34208 | |
| Center For Excellence in Eye Care | |
| Miami, Florida, United States, 33176 | |
| United States, Missouri | |
| St John's Clinic | |
| Springfield, Missouri, United States, 65804 | |
| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| Lynbrook, New York, United States, 11563 | |
| Weill-Cornell Medical College | |
| New York, New York, United States, 10021 | |
| South Shore Eye Care | |
| Wantagh, New York, United States, 11793 | |
| United States, Pennsylvania | |
| Wills Eye Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Northeastern Eye Institute | |
| Scranton, Pennsylvania, United States, 18503 | |
| 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 |
More Information
No publications provided by Rapid Pathogen Screening
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rapid Pathogen Screening |
| ClinicalTrials.gov Identifier: | NCT00921895 History of Changes |
| Obsolete Identifiers: | NCT00799318 |
| Other Study ID Numbers: | 200-003 |
| Study First Received: | June 14, 2009 |
| Results First Received: | August 22, 2012 |
| Last Updated: | August 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Rapid Pathogen Screening:
|
Pink Eye, Viral conjunctivitis Adenoviral conjunctivitis Keratoconjunctivitis |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Inclusion Conjunctival Diseases Eye Diseases Conjunctivitis, Bacterial Eye Infections, Bacterial |
Bacterial Infections Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections Infection |
ClinicalTrials.gov processed this record on May 19, 2013