Interest of Rapid Typing in Adenovirus Infections.

Completed

• Conditions: Adenovirus; Adenovirus Disease; Genotyping

• Registration Number: NCT04056546
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

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 Timeline

• Study Start: 2012-05-29
• Primary Completion: 2014-07-04
• Study Completion: 2014-07-04
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type viral characterization (scale A to G)	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.