NCT04056546

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2014

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

August 13, 2019

Last Update Submit

August 13, 2019

Conditions

AdenovirusAdenovirus DiseaseGenotyping

Keywords

Real-time Polymerase-Chain Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples identified as Adenovirus positive (Hexon quantitative PCR positive samples) by the University Hospital's Virology laboratory, carried out for diagnostic purposes since January 2008, and stored at -80 ° C.

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Marie-Edith LAFON, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 14, 2019

Study Start

May 29, 2012

Primary Completion

July 4, 2014

Study Completion

July 4, 2014

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share