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Completed

NCT Number: NCT03389997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Poitiers

Poitiers, 86021, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal swabs

Diagnostic Test

Iterative nasal swabs will be performed to screen for virus shedding

Primary outcomes

  1. Nasal carriage of virus after a viral respiratory tract infection

    Time frame: Up to 1 year

    Iterative nasal swab to assess the duration of that carryiage

Secondary outcomes

  1. Prevalence of upper and lower respiratory tract infections

    Time frame: 2 years

  2. Prevalence of viral coinfections

    Time frame: 2 years

  3. Prevalence of bacterial coinfections

    Time frame: 2 years

  4. transmission of respiratory tract viral infections by relatives

    Time frame: 2 years

    with a survey filled by the patient

  5. respiratory complications due to respiratory tract viral infections

    Time frame: 2 years

  6. extra-pulmonary symptoms due to respiratory tract viral infections

    Time frame: 2 years

  7. effect of influenza vaccine on viral shedding

    Time frame: 2 years

  8. risk factors to do severe form of respiratory tract infection

    Time frame: 2 years

  9. nosocomial transmission of respiratory tract viral infection

    Time frame: 2 years

  10. delay of chemotherapy due to respiratory infection

    Time frame: 2 years

  11. survival after a respiratory tract viral infection

    Time frame: 30 days

  12. TTV viral load as a marker of immunodepression in oncology and hematology patients

    Time frame: 2 years

    TTV viral load at each visit

  13. Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: ONCOVIR

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2018
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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