Prevalence of Replication of Human Herpes Virus 6 (HHV6)... | NCT03102905

Studies
Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

NCT03102905

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

37Actual

Phase

Not provided

Conditions

HHV6
Exanthema
Hemopathy

Interventions

Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Sep 28, 2018Actual

Completion Date

Sep 28, 2018Actual

First Submitted Date

Mar 31, 2017

First Submission Date that Met QC Criteria

Mar 31, 2017

First Posted Date

Apr 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.	Other	To evaluate the prevalence of the positivity of HHV6 PCR in the skin, during the exanthema in patients hospitalized for haemopathy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Supported for any type of hemopathy.
Allograft, autografted or ungrafted haematopoietic stem cells
Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed
Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash.
Age greater than or equal to 18 years
Patient informed of the protocol by post, not having refused within one month of sending the said courier.

Exclusion Criteria:

Patient who refused the search.
Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any patient hospitalized in the Clinical Hematology and Cellular Therapy department of the CHU Amiens-Picardie between 01/01/2011 and 31/01/2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie		Amiens	Picardie	80054	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases