AdenovirusTYPADENONCT04056546
Interest of Rapid Typing in Adenovirus Infections.
An observational study of Adenovirus and Adenovirus Disease, run by University Hospital, Bordeaux.
Trial summary
Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenovirus, Adenovirus Disease, Genotyping
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2012to 4 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Therefore inclusion in this study of any patient having at least a viral load greater than or equal to 10 ^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies) for the duration study.
Who may be able to join
- viral load greater than or equal to 10 ^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies).
Who cannot join
- Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).
About this study
Official title: Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.
Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.
Read the detailed description
Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics.
They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling.
Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR.
For this purpose, this study proposes a "fast typing" technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.
- Conditions
- Adenovirus, Adenovirus Disease, Genotyping
- Keywords
- Real-time Polymerase-Chain Reaction
- Medical subject headings
- Adenoviridae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Type viral characterization (scale A to G)
sensitivity and specificity of the rapid typing technique, expressed for each strain, relative to the reference method (nucleotide sequencing), among initial diagnostic samples of viral load> 10 ^ 4 / mL.
Measured: At the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start29 May 2012
- Primary completion4 Jul 2014
- Study completion4 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Edith LAFON, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056546
- Sponsor's protocol ID
- CHU BX 2011/08
- Acronym
- TYPADENO
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.
- ClinicalTrials.gov ID
- NCT04056546
- Acronym / sponsor ID
- TYPADENO / CHU BX 2011/08
- Conditions
- Adenovirus, Adenovirus Disease, Genotyping
- Keywords
- Real-time Polymerase-Chain Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 29 May 2012 (actual)
- Primary completion
- 4 Jul 2014 (actual)
- Study completion
- 4 Jul 2014 (actual)
- First posted
- 14 Aug 2019 (actual)
- 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.
Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.
Detailed description
Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics.
They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling.
Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR.
For this purpose, this study proposes a "fast typing" technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Therefore inclusion in this study of any patient having at least a viral load greater than or equal to 10 ^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies) for the duration study.
Key inclusion criteria (1 listed)
- viral load greater than or equal to 10 ^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies).
Key exclusion criteria (1 listed)
- Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).
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
Type viral characterization (scale A to G)
Time frame: At the screening
sensitivity and specificity of the rapid typing technique, expressed for each strain, relative to the reference method (nucleotide sequencing), among initial diagnostic samples of viral load> 10 ^ 4 / mL.
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 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Marie-Edith LAFON, Pr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Adenovirus and Adenovirus Disease, run by University Hospital, Bordeaux.
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 1 inclusion and 1 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Type viral characterization (scale A to G) (time frame: At the screening). 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 14 Aug 2019.