Interest of Rapid Typing in Adenovirus Infections. (TYPADENO)

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.

Study Overview

• Status: Completed
• Conditions: Adenovirus; Genotyping; Adenovirus Disease

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 Type: Observational
• Enrollment (Actual): 296

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Marie-Edith LAFON, Pr, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2012
• Primary Completion (Actual): July 4, 2014
• Study Completion (Actual): July 4, 2014

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Real-time Polymerase-Chain Reaction
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Adenoviridae Infections
• Other Study ID Numbers: CHU BX 2011/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO