Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 2:43 PM
Study NCT ID:
NCT03064620
Status:
UNKNOWN
Last Update Posted:
2017-02-27
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586648', 'term': '10-valent pneumococcal conjugate vaccine'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'S. aureus and S. pneumoniae'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S. pneumoniae carriage', 'timeFrame': '1 Day', 'description': 'S. pneumoniae carriage of children and parents by the different groups'}], 'secondaryOutcomes': [{'measure': 'Carriage of Vaccine-type S. pneumoniae', 'timeFrame': '1 Day', 'description': 'Carriage of Vaccine-type S. pneumoniae in children and parents by the different groups'}, {'measure': 'Carriage of antibiotic resistant S. pneumonia', 'timeFrame': '1 Day', 'description': 'Carriage of antibiotic resistant S. pneumonia in children and parents by the different groups'}, {'measure': 'Carriage of piliated S. pneumonia', 'timeFrame': '1 Day', 'description': 'Carriage of piliated S. pneumonia in children and parents by the different groups'}, {'measure': 'Carriage of MRSA', 'timeFrame': '1 Day', 'description': 'Carriage of MRSA in children and parents by the different groups'}, {'measure': 'S. aureus carriage', 'timeFrame': '1 Day', 'description': 'S. aureus carriage of children and parents by the different groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PCV effects', 'S. pneumoniae carriage', 'S. aureus carriage', 'Indirect vaccination effects', 'Palestinian-Israeli Collaborative Research (PICR)'], 'conditions': ['Streptococcus Pneumoniae']}, 'referencesModule': {'references': [{'pmid': '25593104', 'type': 'BACKGROUND', 'citation': 'Daana M, Rahav G, Hamdan A, Thalji A, Jaar F, Abdeen Z, Jaber H, Goral A, Huppert A, Raz M, Regev-Yochay G; PICR study group. Measuring the effects of pneumococcal conjugate vaccine (PCV7) on Streptococcus pneumoniae carriage and antibiotic resistance: the Palestinian-Israeli Collaborative Research (PICR). Vaccine. 2015 Feb 18;33(8):1021-6. doi: 10.1016/j.vaccine.2015.01.003. Epub 2015 Jan 12.'}, {'pmid': '26245327', 'type': 'BACKGROUND', 'citation': 'Southern J, Roizin H, Daana M, Rubin C, Hasleton S, Cohen A, Goral A, Rahav G, Raz M, Regev-Yochay G; PICR group. Varied utilisation of health provision by Arab and Jewish residents in Israel. Int J Equity Health. 2015 Aug 7;14:63. doi: 10.1186/s12939-015-0193-8.'}, {'pmid': '22539955', 'type': 'BACKGROUND', 'citation': 'Regev-Yochay G, Abullaish I, Malley R, Shainberg B, Varon M, Roytman Y, Ziv A, Goral A, Elhamdany A, Rahav G, Raz M; Palestinian-Israeli Collaborative Research Study Group. Streptococcus pneumoniae carriage in the Gaza strip. PLoS One. 2012;7(4):e35061. doi: 10.1371/journal.pone.0035061. Epub 2012 Apr 23.'}, {'pmid': '22916171', 'type': 'BACKGROUND', 'citation': 'Biber A, Abuelaish I, Rahav G, Raz M, Cohen L, Valinsky L, Taran D, Goral A, Elhamdany A, Regev-Yochay G; PICR Study Group. A typical hospital-acquired methicillin-resistant Staphylococcus aureus clone is widespread in the community in the Gaza strip. PLoS One. 2012;7(8):e42864. doi: 10.1371/journal.pone.0042864. Epub 2012 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:\n\n1. To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.\n2. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus and S. pneumoniae in different regions of the PICR.\n\nStudy design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.', 'detailedDescription': "Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.\n\nPICR districts: 1. Palestinian Authority (PA) - particularly: Bethlehem, Ramallah and Nabulus. 2. East Jerusalem (EJ) 3. Central Israel (IL) - particularly: Rishon Lezion, Bat Yam, Holon 4. Gaza strip (GZ) - 12 regions including cities/villages in central/northern Gaza.\n\nStudy population:\n\nChild (age 0-5y) \\& Parent who attend clinics (for any reason).\n\nExclusion criteria:\n\nParent does not agree to sign informed consent Child or sibling (brother/sister) have already participated.\n\nBoth healthy and ill children are screened. No specific exclusion other than the above.\n\nOnly one child per family (younger child, if more than one available) and one parent (mother, if both are available).\n\nSample size per year:\n\nIL: Central Israel (Hashfela District): 400 pairs of child+parent/surveillance EJ: East Jerusalem: 400 pairs of child+parent/surveillance PA: West Bank cities (Ramallah, Bethlehem \\& Nabulus): 600 pairs of child+parent/surveillance GZ: Gaza strip: 300 pairs of child+parent/surveillance\n\nStudy Period:\n\nMay-August annually 2009 - 2011 - (Part a). May-August biannually 2014-2016-2018-2020 Current study (Part b).\n\nScreening Procedure:\n\n1. Parent signs informed consent\n2. Put Barcode stickers on informed consent, questionnaire, swabs and daily list\n3. Fill questionnaire with parent.\n4. Fill physician questionnaire\n5. Nasal \\& nasopharyngeal swab of child and parent.\n6. Fill daily working table.\n7. Write the number of refusals (parents who refused) on daily table.\n8. Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO.\n\nSwabbing:\n\n1. First swab the child and then follow with the parent.\n2. First perform nasal swab (for S. aureus) using cotton-tip swab placed into Amies transport Media (Blue) and follow with nasopharyngeal swab ( for S. pneumoniae) using rayon-tipped aluminum shaft swab placed in Amies transport Media (Orange).\n3. Slightly wet the nasal swab with sterile saline. Swab both anterior nares.\n4. Nasopharyngeal swab of only through one nostril - gently, quickly and deep to nasopharynx - until you touch the nasopharyngeal wall.\n\nSwab transfer to lab:\n\nIf swabs are stored overnight before transfer - keep in 40C (fridge). Within 24h swabs must reach the central laboratory (Dr. Regev-Yochay's Lab at Sheba Medical Center)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Child (age 0-5y) \\& Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any child younger than 5 years, visiting the participating clinics during the surveillance period\n\nExclusion Criteria:\n\n* Older than 5 years\n* Previously participated in the study.\n* Sibling has participated in the study.\n* Parent does not agree to sign informed consent'}, 'identificationModule': {'nctId': 'NCT03064620', 'acronym': 'PICRcarriage', 'briefTitle': 'PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study', 'orgStudyIdInfo': {'id': '8024-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Israel PCV13', 'description': 'Children and their parents living in central Israel and visiting primary pediatric clinics of Hashfela District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year.', 'interventionNames': ['Biological: PCV']}, {'label': 'East Jerusalem PCV13', 'description': 'Children and their parents living in East Jerusalem and visiting primary pediatric clinics of Jerusalem District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year.', 'interventionNames': ['Biological: PCV']}, {'label': 'Palestine PCV7 PCV10', 'description': 'Children and their parents living in major cities of the Palestinian Authority and visiting private primary pediatric clinics, for any reason during the surveillance period each year.', 'interventionNames': ['Biological: PCV']}], 'interventions': [{'name': 'PCV', 'type': 'BIOLOGICAL', 'otherNames': ['PCV7', 'PCV10', 'PCV13'], 'description': 'PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011', 'armGroupLabels': ['East Jerusalem PCV13', 'Israel PCV13', 'Palestine PCV7 PCV10']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gili Regev-Yochay', 'role': 'CONTACT', 'phone': '0526666197'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Gili Regev-Yochay, MD', 'role': 'CONTACT', 'email': 'gili.regev.y@gmail.com', 'phone': '0526666197'}, {'name': 'Ziad Abdeen, PhD', 'role': 'CONTACT', 'email': 'zabdeen13@gmail.com'}], 'overallOfficials': [{'name': 'Dror Harats, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'IRB Committee Sheba Medical Center Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Palestinian-Israeli Collaborative Research (PICR)', 'class': 'OTHER'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'The Israeli National Institute for Health Policy Research', 'class': 'UNKNOWN'}, {'name': 'Maccabi Healthcare Services, Israel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Infect Dis Epi Section, Gertner', 'investigatorFullName': 'Gili Regev-Yochay MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}