ADenoVirus Initiative Study in Epidemiology in Germany

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by NicOx
Sponsor:
Information provided by (Responsible Party):
NicOx
ClinicalTrials.gov Identifier:
NCT02054273
First received: January 17, 2014
Last updated: February 3, 2014
Last verified: January 2014
  Purpose

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.


Condition
Viral Conjunctivitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by NicOx:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox


Estimated Enrollment: 500
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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 Germany. The planned duration of the study is one year from the first patient visit to the last patient visit.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054273

Contacts
Contact: Brigitte Duquesroix, MD 33 (0)4 97 24 53 00 duquesroix@nicox.com

Locations
Germany
Uwe Pleyer Not yet recruiting
Berlin, Germany, 13353
Contact: Uwe Pleyer, MD       uwe.pleyer@charite.de   
Principal Investigator: Uwe Pleyer, MD         
University eye hospital Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Daniel Böhringer, MD       daniel.boehringer@uniklinik-freiburg.de   
Principal Investigator: Daniel Boehringer, MD         
Florian Seidensticker Not yet recruiting
Hannover, Germany, 30625
Contact: Florian Seidensticker, MD       seidensticker.florian@mh-hannover.de   
Principal Investigator: Florian Seidensticker, MD         
Dr. Thomas Kaercher Recruiting
Heidelberg, Germany, 69121
Contact: Thomas Kaercher, MD       thomas.kaercher@meibomius.de   
Principal Investigator: Thomas Kaercher, MD         
Dr. Michael Hyppa Recruiting
Karlsruhe, Germany, 76131
Contact: Michael Hyppa, MD       m-e.hyppa@t-online.de   
Principal Investigator: Michael Hyppa, MD         
Städtisches Klinikum Karlsruhe Augenklinik Recruiting
Karlsruhe, Germany, 76133
Contact: Albert J. Augustin, MD       augenklinik@klinikum-karlsruhe.de   
Principal Investigator: Albert J. Augustin, MD         
Karlheinz Krüger Recruiting
Karlsruhe, Germany, 76229
Contact: Karlheinz Krüger, MD       augen-kk@web.de   
Principal Investigator: Karlheinz Krüger, MD         
Stefan Koinzer Not yet recruiting
Kiel, Germany, 24105
Contact: Stefan Koinzer, MD       koinzer@auge.uni-kiel.de   
Principal Investigator: Stefan Koinzer, MD         
Poliklinik Leiter Recruiting
Köln, Germany, 50937
Contact: Ludwig M. Heindl, MD       ludwig.heindl@uk-koeln.de   
Principal Investigator: Ludwig M. Heindl, MD         
Katrin Lorenz Not yet recruiting
Mainz, Germany, 55131
Contact: Katrin Lorenz       katrin.lorenz@unimedizin-mainz.de   
Principal Investigator: Katrin Lorenz, MD         
Klinikum der Universität München Recruiting
München, Germany, 80336
Contact: Elisabeth M. Messmer, MD       Elisabeth.Messmer@med.uni-muenchen.de   
Principal Investigator: Elisabeth M. Messmer, MD         
Ulrich Thelen Recruiting
Münster, Germany, 48143
Contact: Ulrich Thelen, MD       augendiener@augenaerzte-muenster.de   
Principal Investigator: Ulrich Thelen, MD         
Ines Lanzl Recruiting
Prien a. Chiemsee, Germany, 83209
Contact: Ines Lanzl, MD       ines@prof-lanzl.de   
Principal Investigator: Ines Lanzl, MD         
Sponsors and Collaborators
NicOx
Investigators
Principal Investigator: Elizabeth M Messmer, MD University Hospital Munich
  More Information

No publications provided

Responsible Party: NicOx
ClinicalTrials.gov Identifier: NCT02054273     History of Changes
Other Study ID Numbers: ADVISE Germany
Study First Received: January 17, 2014
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by NicOx:
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections

ClinicalTrials.gov processed this record on August 21, 2014