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Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients (ONCOVIR)

Primary Purpose

Respiratory Tract Viral Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasal swabs
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Viral Infection focused on measuring respiratory tract infections, virus shedding, cancer, Immunocompromised Host

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University Hospital of PoitiersRecruiting

Outcomes

Primary Outcome Measures

Nasal carriage of virus after a viral respiratory tract infection
Iterative nasal swab to assess the duration of that carryiage

Secondary Outcome Measures

Prevalence of upper and lower respiratory tract infections
Prevalence of viral coinfections
Prevalence of bacterial coinfections
transmission of respiratory tract viral infections by relatives
with a survey filled by the patient
respiratory complications due to respiratory tract viral infections
extra-pulmonary symptoms due to respiratory tract viral infections
effect of influenza vaccine on viral shedding
risk factors to do severe form of respiratory tract infection
nosocomial transmission of respiratory tract viral infection
delay of chemotherapy due to respiratory infection
survival after a respiratory tract viral infection
TTV viral load as a marker of immunodepression in oncology and hematology patients
TTV viral load at each visit
Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection

Full Information

First Posted
December 21, 2017
Last Updated
February 17, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03389997
Brief Title
Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients
Acronym
ONCOVIR
Official Title
Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
May 9, 2025 (Anticipated)
Study Completion Date
May 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The development of multiplex polymerase chain reaction (PCR) tests has greatly improved the diagnosis of respiratory tract viral infections by increasing its sensitivity and the diversity of viral species detected. However, there are few data concerning respiratory tract viral infections amongst hematology and oncology patients. Especially, the duration of viral shedding following an infection has not been much studied whereas it is a source of inter-individual transmission between immunocompromised patients who are more likely to develop severe disease. Studies conducted so far concerned mainly hematology patients. They have shown that viral carriage could last up to one month and a half in some patients with hematological malignancy. The aim of this study is to determine the duration of the viral shedding in patients from hematology and oncology units after a respiratory tract viral infection for the ten main viruses involved in order to better manage these infections and to better prevent their transmission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Viral Infection
Keywords
respiratory tract infections, virus shedding, cancer, Immunocompromised Host

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Iterative nasal swabs will be performed to screen for virus shedding
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
nasal swabs
Intervention Description
Iterative nasal swabs will be performed to screen for virus shedding
Primary Outcome Measure Information:
Title
Nasal carriage of virus after a viral respiratory tract infection
Description
Iterative nasal swab to assess the duration of that carryiage
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Prevalence of upper and lower respiratory tract infections
Time Frame
2 years
Title
Prevalence of viral coinfections
Time Frame
2 years
Title
Prevalence of bacterial coinfections
Time Frame
2 years
Title
transmission of respiratory tract viral infections by relatives
Description
with a survey filled by the patient
Time Frame
2 years
Title
respiratory complications due to respiratory tract viral infections
Time Frame
2 years
Title
extra-pulmonary symptoms due to respiratory tract viral infections
Time Frame
2 years
Title
effect of influenza vaccine on viral shedding
Time Frame
2 years
Title
risk factors to do severe form of respiratory tract infection
Time Frame
2 years
Title
nosocomial transmission of respiratory tract viral infection
Time Frame
2 years
Title
delay of chemotherapy due to respiratory infection
Time Frame
2 years
Title
survival after a respiratory tract viral infection
Time Frame
30 days
Title
TTV viral load as a marker of immunodepression in oncology and hematology patients
Description
TTV viral load at each visit
Time Frame
2 years
Title
Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Hematological stem cell and solid organ recipients No health insurance protected people
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucile DECANTER, CRA
Phone
0549443203
Ext
33
Email
lucile.decanter@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Andy LARIVIERE, residents
Phone
0549442774
Ext
33
Email
andy.lariviere@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blandine RAMMAERT, MD,PhD
Organizational Affiliation
CHU of POITIERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blandine Rammaert
Phone
+33549441948
Email
blandine.rammaert@chu-poitiers.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients

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