PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
PICRcarriage
1 other identifier
observational
12,800
1 country
1
Brief Summary
Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:
- 1.To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.
- 2.To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus and S. pneumoniae in different regions of the PICR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 27, 2017
February 1, 2017
6.3 years
March 29, 2016
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
S. pneumoniae carriage
S. pneumoniae carriage of children and parents by the different groups
1 Day
Secondary Outcomes (5)
Carriage of Vaccine-type S. pneumoniae
1 Day
Carriage of antibiotic resistant S. pneumonia
1 Day
Carriage of piliated S. pneumonia
1 Day
Carriage of MRSA
1 Day
S. aureus carriage
1 Day
Study Arms (3)
Israel PCV13
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.
East Jerusalem PCV13
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.
Palestine PCV7 PCV10
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.
Interventions
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
Eligibility Criteria
Child (age 0-5y) \& Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.
You may qualify if:
- Any child younger than 5 years, visiting the participating clinics during the surveillance period
You may not qualify if:
- Older than 5 years
- Previously participated in the study.
- Sibling has participated in the study.
- Parent does not agree to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel, 5265601, Israel
Related Publications (4)
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: 25593104BACKGROUNDSouthern 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: 26245327BACKGROUNDRegev-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: 22539955BACKGROUNDBiber 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.
PMID: 22916171BACKGROUND
Biospecimen
S. aureus and S. pneumoniae
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Dror Harats, Prof.
IRB Committee Sheba Medical Center Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Infect Dis Epi Section, Gertner
Study Record Dates
First Submitted
March 29, 2016
First Posted
February 27, 2017
Study Start
April 1, 2014
Primary Completion
August 1, 2020
Study Completion
January 1, 2022
Last Updated
February 27, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share