Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-31 @ 1:34 AM
Study NCT ID:
NCT01112592
Status:
UNKNOWN
Last Update Posted:
2013-02-27
First Post:
2010-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-26', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure NET formation in patients with recurrent infections', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NETs', 'Infections', 'Neutrophil function'], 'conditions': ['Pyogenic Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent, persistent, or unusual infections\n* Referred for Neutrophil Functions\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01112592', 'acronym': 'NETs', 'briefTitle': 'NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Ability of Neutrophils From Patients With Recurrent Infections to Produce Neutrophil Extracellular Traps (NET).', 'orgStudyIdInfo': {'id': 'MMC-10156-09CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ronit Gavrieli, MSc', 'role': 'CONTACT', 'email': 'ronitgav@clalit.org.il', 'phone': '972-9-7472399'}, {'name': 'Baruch Wolach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ronit Gavrieli, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sivan Berger-Achituv, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tamar Kovalsky, Nurse', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Ronit Gavrieli, MSc', 'role': 'CONTACT', 'email': 'ronitgav@clalit.org.il', 'phone': '972-9-7472399'}], 'overallOfficials': [{'name': 'Baruch Wolach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Max Planck Institute for Infection Biology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}