Interest of Rapid Typing in Adenovirus Infections.

Adenovirus Clinical Trial

— TYPADENO  

Official title:

Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056546
• Other study ID #: CHU BX 2011/08
• Status: Completed
• Start date: May 29, 2012
• Est. completion date: July 4, 2014

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: July 4, 2014
• Est. primary completion date: July 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• 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).

Exclusion Criteria:

• Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus
• Adenovirus Disease
• Genotyping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the screening