Respiratory Tract Viral InfectionONCOVIRNCT03389997
Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients
A study testing nasal swabs in people with Respiratory Tract Viral Infection, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Viral Infection
- What is being tested?
- nasal swabs
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2017to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hematological stem cell and solid organ recipients
- No health insurance
- protected people
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Respiratory Tract Viral Infection
- Being tested
- nasal swabs
- Keywords
- respiratory tract infections, virus shedding, cancer, Immunocompromised Host
- Medical subject headings
- Respiratory Tract Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal swabsDiagnostic test
Iterative nasal swabs will be performed to screen for virus shedding
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal carriage of virus after a viral respiratory tract infection
Iterative nasal swab to assess the duration of that carryiage
Measured: Up to 1 year
Secondary outcomes (13)
Prevalence of upper and lower respiratory tract infections
Measured: 2 years
Prevalence of viral coinfections
Measured: 2 years
Prevalence of bacterial coinfections
Measured: 2 years
transmission of respiratory tract viral infections by relatives
with a survey filled by the patient
Measured: 2 years
respiratory complications due to respiratory tract viral infections
Measured: 2 years
extra-pulmonary symptoms due to respiratory tract viral infections
Measured: 2 years
effect of influenza vaccine on viral shedding
Measured: 2 years
risk factors to do severe form of respiratory tract infection
Measured: 2 years
nosocomial transmission of respiratory tract viral infection
Measured: 2 years
delay of chemotherapy due to respiratory infection
Measured: 2 years
survival after a respiratory tract viral infection
Measured: 30 days
TTV viral load as a marker of immunodepression in oncology and hematology patients
TTV viral load at each visit
Measured: 2 years
Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start7 Feb 2017
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Viral InfectionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Iterative nasal swabs will be performed to screen for virus shedding
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- France CAZENAVE-ROBLOT, MD,PhD, Principal investigator, CHU of POITIERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389997
- Sponsor's protocol ID
- ONCOVIR
- Acronym
- ONCOVIR
- Status last verified
- Apr 2024
- First submitted
- 21 Dec 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients
- ClinicalTrials.gov ID
- NCT03389997
- Acronym / sponsor ID
- ONCOVIR / ONCOVIR
- Conditions
- Respiratory Tract Viral Infection
- Keywords
- respiratory tract infections, virus shedding, cancer, Immunocompromised Host
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Iterative nasal swabs will be performed to screen for virus shedding
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Hematological stem cell and solid organ recipients
- No health insurance
- protected people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal swabsIterative nasal swabs will be performed to screen for virus shedding | Diagnostic test | – |
Primary outcome
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
13 secondary outcomes
Prevalence of upper and lower respiratory tract infections
Time frame: 2 years
Prevalence of viral coinfections
Time frame: 2 years
Prevalence of bacterial coinfections
Time frame: 2 years
transmission of respiratory tract viral infections by relatives
Time frame: 2 years
respiratory complications due to respiratory tract viral infections
Time frame: 2 years
extra-pulmonary symptoms due to respiratory tract viral infections
Time frame: 2 years
effect of influenza vaccine on viral shedding
Time frame: 2 years
risk factors to do severe form of respiratory tract infection
Time frame: 2 years
nosocomial transmission of respiratory tract viral infection
Time frame: 2 years
delay of chemotherapy due to respiratory infection
Time frame: 2 years
survival after a respiratory tract viral infection
Time frame: 30 days
TTV viral load as a marker of immunodepression in oncology and hematology patients
Time frame: 2 years
Correlation between TTV viral load and duration of viral shedding and severity of respiratory tract infection
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France CAZENAVE-ROBLOT, MD,PhD principal investigator
CHU of POITIERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal swabs in people with Respiratory Tract Viral Infection, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal carriage of virus after a viral respiratory tract infection (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.