Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03064620
Acronym
PICRcarriage
Enrollment
12800
Registered
2017-02-27
Start date
2014-04-30
Completion date
2022-01-31
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcus Pneumoniae

Keywords

PCV effects, S. pneumoniae carriage, S. aureus carriage, Indirect vaccination effects, Palestinian-Israeli Collaborative Research (PICR)

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

Detailed 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).

Interventions

BIOLOGICALPCV

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

Sponsors

Palestinian-Israeli Collaborative Research (PICR)
CollaboratorOTHER
United States Agency for International Development (USAID)
CollaboratorFED
The Israeli National Institute for Health Policy Research
CollaboratorUNKNOWN
Maccabi Healthcare Services, Israel
CollaboratorOTHER
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
S. pneumoniae carriage1 DayS. pneumoniae carriage of children and parents by the different groups

Secondary

MeasureTime frameDescription
Carriage of Vaccine-type S. pneumoniae1 DayCarriage of Vaccine-type S. pneumoniae in children and parents by the different groups
Carriage of antibiotic resistant S. pneumonia1 DayCarriage of antibiotic resistant S. pneumonia in children and parents by the different groups
Carriage of piliated S. pneumonia1 DayCarriage of piliated S. pneumonia in children and parents by the different groups
Carriage of MRSA1 DayCarriage of MRSA in children and parents by the different groups
S. aureus carriage1 DayS. aureus carriage of children and parents by the different groups

Countries

Israel

Contacts

Primary ContactGili Regev-Yochay, MD
gili.regev.y@gmail.com0526666197
Backup ContactZiad Abdeen, PhD
zabdeen13@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026