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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Viral Infection
• Intervention / Treatment: Diagnostic test: nasal swabs

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucile DECANTER, CRA; Phone Number: 33 0549443203; Email: lucile.decanter@chu-poitiers.fr
• Study Contact Backup: Name: Andy LARIVIERE, residents; Phone Number: 33 0549442774; Email: andy.lariviere@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86021
    • University Hospital of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	with a survey filled by the patient	2 years
respiratory complications due to respiratory tract viral infections		2 years
extra-pulmonary symptoms due to respiratory tract viral infections		2 years
effect of influenza vaccine on viral shedding		2 years
risk factors to do severe form of respiratory tract infection		2 years
nosocomial transmission of respiratory tract viral infection		2 years
delay of chemotherapy due to respiratory infection		2 years
survival after a respiratory tract viral infection		30 days
TTV viral load as a marker of immunodepression in oncology and hematology patients	TTV viral load at each visit	2 years
Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection		2 years

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: France CAZENAVE-ROBLOT, MD,PhD, CHU of POITIERS

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cancer; Immunocompromised Host; respiratory tract infections; virus shedding
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ONCOVIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No