NCT03389997

Brief Summary

The purpose of this study is to assess the duration of the viral shedding in hematology and oncology patients after a respiratory tract viral infection. This duration has not been much studied in that population whereas it is probably longer than that in immunocompetent patients. Thereby it may be a source of transmission amongst these immunocompromised patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 7, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

7 years

First QC Date

December 21, 2017

Last Update Submit

April 18, 2024

Conditions

Respiratory Tract Viral Infection

Keywords

respiratory tract infectionsvirus sheddingcancerImmunocompromised Host

Outcome Measures

Primary Outcomes (1)

  • Nasal carriage of virus after a viral respiratory tract infection

    Iterative nasal swab to assess the duration of that carryiage

    Up to 1 year

Secondary Outcomes (13)

  • Prevalence of upper and lower respiratory tract infections

    2 years

  • Prevalence of viral coinfections

    2 years

  • Prevalence of bacterial coinfections

    2 years

  • transmission of respiratory tract viral infections by relatives

    2 years

  • respiratory complications due to respiratory tract viral infections

    2 years

  • +8 more secondary outcomes

Interventions

nasal swabsDIAGNOSTIC_TEST

Iterative nasal swabs will be performed to screen for virus shedding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with solid organ cancer or haematological malignancy with or without chemotherapy
  • Having symptoms of upper and/or lower respiratory tract infection
  • Virus detected by PCR in nasal sample
  • Signature of consent

You may not qualify if:

  • Hematological stem cell and solid organ recipients
  • No health insurance
  • protected people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsNeoplasms

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • France CAZENAVE-ROBLOT, MD,PhD

    CHU of POITIERS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Iterative nasal swabs will be performed to screen for virus shedding
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 4, 2018

Study Start

February 7, 2017

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)