A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

Sponsor
Rapid Pathogen Screening (Industry)
Overall Status
Completed
CT.gov ID
NCT00921895
Collaborator
(none)
128
8
1
24
16
0.7

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
  • Device: RPS Adeno Detector IV
N/A

Detailed Description

The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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.
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

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

  1. 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

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
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

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.
Responsible Party:
Rapid Pathogen Screening
ClinicalTrials.gov Identifier:
NCT00921895
Other Study ID Numbers:
  • 200-003
  • NCT00799318
First Posted:
Jun 16, 2009
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Rapid Pathogen Screening
Additional relevant MeSH terms:

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.
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

1. Primary Outcome
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

[Not Specified]

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
Organization Rapid Pathogen Screening, Inc.
Phone 941-556-1853
Email sambursky@rpsdetectors.com
Responsible Party:
Rapid Pathogen Screening
ClinicalTrials.gov Identifier:
NCT00921895
Other Study ID Numbers:
  • 200-003
  • NCT00799318
First Posted:
Jun 16, 2009
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021