PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study

Streptococcus Pneumoniae Clinical Trial

— PICRcarriage  

Official title:

PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064620
• Other study ID #: 8024-10
• 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
• 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:

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

PICR 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.

Study population:

Child (age 0-5y) & Parent who attend clinics (for any reason).

Exclusion criteria:

Parent does not agree to sign informed consent Child or sibling (brother/sister) have already participated.

Both healthy and ill children are screened. No specific exclusion other than the above.

Only one child per family (younger child, if more than one available) and one parent (mother, if both are available).

Sample size per year:

IL: 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

Study Period:

May-August annually 2009 - 2011 - (Part a). May-August biannually 2014-2016-2018-2020 Current study (Part b).

Screening Procedure:

1. Parent signs informed consent

2. Put Barcode stickers on informed consent, questionnaire, swabs and daily list

3. Fill questionnaire with parent.

4. Fill physician questionnaire

5. Nasal & nasopharyngeal swab of child and parent.

6. Fill daily working table.

7. Write the number of refusals (parents who refused) on daily table.

8. Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO.

Swabbing:

1. First swab the child and then follow with the parent.

2. 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).

3. Slightly wet the nasal swab with sterile saline. Swab both anterior nares.

4. Nasopharyngeal swab of only through one nostril - gently, quickly and deep to nasopharynx - until you touch the nasopharyngeal wall.

Swab transfer to lab:

If 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12800
• Est. completion date: January 2022
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Any child younger than 5 years, visiting the participating clinics during the surveillance period

Exclusion Criteria:

• Older than 5 years

• Previously participated in the study.

• Sibling has participated in the study.

• Parent does not agree to sign informed consent

Related Conditions & MeSH terms

• Pneumonia
• Streptococcus Pneumoniae

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