Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ADenoVirus Initiative Study in Epidemiology in Spain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254330
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
NicOx

Tracking Information
First Submitted Date September 29, 2014
First Posted Date October 1, 2014
Last Update Posted Date January 10, 2017
Study Start Date July 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2014)
Frequency of patients with adenovirus conjunctivitis [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]
The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2014)
  • Seasonality and geographic repartition observed. [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]
    The number of patients with adenovirus conjunctivitis who visited the ophthalmologist in spring, summer, autumn and winter and their geographic area (e.g. by hospital, by area).
  • Clinical profiles of the patients [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]
    The percentage of each eye signs and symptoms, the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests, the number or follow-up visit done and the correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).
  • Resource utilization during the treatment and evaluation of the costs [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]
    Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), and associated costs (which would be calculated by applying unit costs to resource use).
  • Patient/parent absenteeism linked to this disease. [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]
    Number of days out of work and/or out of school linked to this disease.
  • Safety assessment [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]
    Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title ADenoVirus Initiative Study in Epidemiology in Spain
Official Title Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis
Brief Summary The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.
Detailed Description Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Spain. The planned duration of the study is one year from the first patient visit to the last patient visit.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any female and male patients from one year of age with signs and symptoms of acute conjunctivitis either seen during ophthalmology consultations or who are in the emergency room or hospitalized, can be enrolled in the study
Condition Viral Conjunctivitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2017)
386
Original Estimated Enrollment
 (submitted: September 29, 2014)
500
Actual Study Completion Date August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
  • Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
  • No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

  • Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
  • Previous enrolment in the present study.
  • Any direct involvement with the study conduct at site or any family link with study site staff.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02254330
Other Study ID Numbers ADVISE Spain
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NicOx
Study Sponsor NicOx
Collaborators Not Provided
Investigators
Principal Investigator: Jose Manuel Benitez Del Castillo, MD Ocumed Clinica Oftalmologica
PRS Account NicOx
Verification Date January 2017