Sub Populations of Immune Cells in Influenza A and B Patients

NCT03366402 | Unknown

• 1 other identifier: 0015-16-LND
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study designed to examine changes of immune system cells sub-populations during influenza disease. Several parameters will be examined, such as: amount of sub populations, clinical parameters (body temperature and number of hospitalization days). The participants are children that are hospitalized in the Laniado hospital pediatric department.

Conditions

Influenza A and B

Outcome Measures

Primary Outcomes (1)

• Quantifing the B, T and NK populations of lymphocytes during different stages of the disease caused by Infuenza A H1N1.

  The identification and quantification of the different cell types are performed by FACS method, the cell receptors that were marked were CD31, CD19, CD4, CD3, CD45, CD8, CD56. The primary outcome measure was defined as the absolute number of lymphocytes of each sub population. Thus, farther allowing us to follow both absolute numbers and relative percentage of the whole.

  2 years

Study Arms (2)

Influenza A

Diagnostic Test: RT-PCR H1N1

Influenza B

Diagnostic Test: RT-PCR H1N1

Interventions

RT-PCR H1N1 DIAGNOSTIC_TEST

At the first stage an upper respiratory swab was taken to determine the presence of Infuenza A H1N1 (the virus identification was done by RT - PCR). Then the different subtypes of lymphocytes were quantified at different stages of the disease. The identification and quantification of the different cell types were performed by FACS method, the cell receptors that were marked were CD31, CD19, CD4, CD3, CD45, CD8, CD56.

Influenza A; Influenza B

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children hospitalized at the pediatric department with signs and symptoms of flu.

You may qualify if:

• Children aged 0-16
• Have signed a written consent by parents or legal guardians
• Signs and symptoms of flu

You may not qualify if:

• Immune system disease

Sponsors & Collaborators

• Dr. Nechama Sharon: lead

Study Sites (1)

Sharon Nechama, Laniado Hospital

Netanya, Israel

RECRUITING

Central Study Contacts

Nechama Sharon, Dr.

CONTACT

+972-9-8604738; nsharon@laniado.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pediatric Hemato-Oncology Unit, Depute Director Department of Pediatrics

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 8, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: January 4, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)