NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Max Planck Institute for Infection Biology
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01112592
First received: April 27, 2010
Last updated: February 26, 2013
Last verified: March 2012
  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).

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Measure NET formation in patients with recurrent infections [ Time Frame: One year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01112592     History of Changes
Other Study ID Numbers: MMC-10156-09CTIL
Study First Received: April 27, 2010
Last Updated: February 26, 2013
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
NETs
Infections
Neutrophil function

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on August 19, 2014