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NETs Formation in Patients With Recurrent Pyogenic Infections (NETS) (NETs)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112592
First Posted: April 28, 2010
Last Update Posted: February 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Max Planck Institute for Infection Biology
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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.

Condition
Pyogenic Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Ability of Neutrophils From Patients With Recurrent Infections to Produce Neutrophil Extracellular Traps (NET).

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Measure NET formation in patients with recurrent infections [ Time Frame: One year ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  • Patients with recurrent, persistent, or unusual infections
  • Referred for Neutrophil Functions

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112592


Contacts
Contact: Ronit Gavrieli, MSc 972-9-7472399 ronitgav@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Ronit Gavrieli, MSc    972-9-7472399    ronitgav@clalit.org.il   
Principal Investigator: Baruch Wolach, MD         
Sub-Investigator: Ronit Gavrieli, MSc         
Sub-Investigator: Sivan Berger-Achituv, MD         
Sub-Investigator: Tamar Kovalsky, Nurse         
Sponsors and Collaborators
Meir Medical Center
Max Planck Institute for Infection Biology
Investigators
Principal Investigator: Baruch Wolach, MD Meir Medical Center
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01112592     History of Changes
Other Study ID Numbers: MMC-10156-09CTIL
First Submitted: April 27, 2010
First Posted: April 28, 2010
Last Update Posted: February 27, 2013
Last Verified: March 2012

Keywords provided by Meir Medical Center:
NETs
Infections
Neutrophil function

Additional relevant MeSH terms:
Infection
Communicable Diseases