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

Respiratory Tract Viral Infection Clinical Trial

— ONCOVIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389997
• Other study ID #: ONCOVIR
• Status: Completed
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Respiratory Tract Viral Infection
• Virus Diseases

Intervention

Diagnostic Test:
• nasal swabs
Iterative nasal swabs will be performed to screen for virus shedding

Locations

Country	Name	City	State
France	University Hospital of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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