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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04056546
Other study ID # CHU BX 2011/08
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


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
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