NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)

Pyogenic Infections Clinical Trial

— NETs  

Official title:

The Ability of Neutrophils From Patients With Recurrent Infections to Produce Neutrophil Extracellular Traps (NET).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112592
• Other study ID #: MMC-10156-09CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2010
• Last updated: February 26, 2013
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Ronit Gavrieli, MSc
• Phone: 972-9-7472399
• Email: ronitgav[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial Summary

We aim to study if pathological NETs formation could be the underlying pathology among patients with recurrent infections and a normal screening of the immune system.

Description:

Our laboratory at Meir Medical Center, Kfar Saba, is the country's main center for neutrophil function, and serves about 80% of Israel's population. Patients are referred subsequent to recurrent, persistent, or unusual infections and after completing preliminary screening of the immune system and ruling out a humoral, cellular or complement immune deficiency. Initial workup includes chemotaxis, superoxide production (SOP), and bactericidal activity (BA). Based on test findings, further evaluation for a qualitative phagocytic disorder is conducted. Overall, impairment of phagocytic activity is found in about 33% (impaired chemotaxis in 16%, SOP in 6%, and BA in 24%). In the other 67%, no impairment of the immune function is found that can explain their tendency for recurrent pyogenic infections.

In 2004 a novel function of the neutrophil was identified: formation of neutrophil extracellular traps (NETs). Apparently, neutrophils are able to extrude part of their cellular contents in the form of DNA, histones and proteases, to form extra cellular NETS that trap and kill bacterial pathogens without the need for phagocytosis. We aim to study if pathological NETs formation could be the underlying pathology among these patients with recurrent infections and a normal screening of the immune system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with recurrent, persistent, or unusual infections

• Referred for Neutrophil Functions

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pyogenic Infections

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Max Planck Institute for Infection Biology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure NET formation in patients with recurrent infections		One year	No