ADenoVirus Initiative Study in Epidemiology in Germany

NCT ID: NCT02054273

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Viral Conjunctivitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NicOx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth M Messmer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Munich

Locations

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Uwe Pleyer

Berlin, , Germany

Site Status

Poliklinik Leiter

Cologne, , Germany

Site Status

University eye hospital Freiburg

Freiburg im Breisgau, , Germany

Site Status

Florian Seidensticker

Hanover, , Germany

Site Status

Dr. Thomas Kaercher

Heidelberg, , Germany

Site Status

Dr. Michael Hyppa

Karlsruhe, , Germany

Site Status

Städtisches Klinikum Karlsruhe Augenklinik

Karlsruhe, , Germany

Site Status

Karlheinz Krüger

Karlsruhe, , Germany

Site Status

Stefan Koinzer

Kiel, , Germany

Site Status

Katrin Lorenz

Mainz, , Germany

Site Status

Klinikum der Universität München

München, , Germany

Site Status

Ulrich Thelen

Münster, , Germany

Site Status

Ines Lanzl

Prien A. Chiemsee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ADVISE Germany

Identifier Type: -

Identifier Source: org_study_id

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