Viral ConjunctivitisNCT02054234
ADenoVirus Initiative Study in Epidemiology in France
An observational study of Viral Conjunctivitis, run by NicOx at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Viral Conjunctivitis
- How many people
- 357 participants
- Where
- 19 sitesFrance
- Study dates
- Jun 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Hôpital Avicenne
Bobigny
Groupe hospitalier Pellegrin
Bordeaux
CHU BREST- Hôpital Morvan
Brest, 29609
Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU de Lille
Lille
Hospices Civils de Lyon
Lyon
Hôpital de la Timone
Marseille, 13385
Hopital Nord
Marseille, 13
GABISSON
Marseille
CH Nantes
Nantes
Centre hospitalier Saint Roch
Nice, 06000
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Groupe Hospitalier La Pitié Salpêtrière-Charles Foix
Paris, 75013
Fondation Rothschild
Paris, 75019
Hôpital Tenon
Paris, 75970
Hôpital Hôtel Dieu
Paris
Hopital Pontchaillou
Rennes
Nouvel Hôpital Civil
Strasbourg, 67000
CHU Hôpital Bretonneau
Tours, 37044
About this study
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
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.
Read the 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 France. The planned duration of the study is one year from the first patient visit to the last patient visit.
- Conditions
- Viral Conjunctivitis
- Keywords
- Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
- Medical subject headings
- Conjunctivitis, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with adenovirus conjunctivitis
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.
Measured: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Tuil, Principal investigator, CHNO Des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054234
- Sponsor's protocol ID
- ADVISE France
- Status last verified
- Feb 2015
- First submitted
- 17 Jan 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02054234
- Acronym / sponsor ID
- ADVISE France
- Conditions
- Viral Conjunctivitis
- Keywords
- Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 France. The planned duration of the study is one year from the first patient visit to the last patient visit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Tuil principal investigator
CHNO Des Quinze-Vingts
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Conjunctivitis, run by NicOx at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.