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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03064620
Other study ID # 8024-10
Secondary ID
Status Recruiting
Phase N/A
First received March 29, 2016
Last updated February 22, 2017
Start date April 2014
Est. completion date January 2022

Study information

Verified date February 2017
Source Sheba Medical Center
Contact Gili Regev-Yochay, MD
Phone 0526666197
Email gili.regev.y@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PCV
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

Locations

Country Name City State
Israel Sheba Medical Center Ramat-Gan

Sponsors (5)

Lead Sponsor Collaborator
Sheba Medical Center Maccabi Healthcare Services Research Fund, Palestinian-Israeli Collaborative Research (PICR), The Israeli National Institute for Health Policy Research, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary S. pneumoniae carriage S. pneumoniae carriage of children and parents by the different groups 1 Day
Secondary Carriage of Vaccine-type S. pneumoniae Carriage of Vaccine-type S. pneumoniae in children and parents by the different groups 1 Day
Secondary Carriage of antibiotic resistant S. pneumonia Carriage of antibiotic resistant S. pneumonia in children and parents by the different groups 1 Day
Secondary Carriage of piliated S. pneumonia Carriage of piliated S. pneumonia in children and parents by the different groups 1 Day
Secondary Carriage of MRSA Carriage of MRSA in children and parents by the different groups 1 Day
Secondary S. aureus carriage S. aureus carriage of children and parents by the different groups 1 Day
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