Clinical trial NCT03064620: PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
Official title: PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Streptococcus Pneumoniae
Keywords: PCV effects
S. pneumoniae carriage
S. aureus carriage
Indirect vaccination effects
Palestinian-Israeli Collaborative Research (PICR)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Palestinian-Israeli Collaborative Research (PICR)
name: United States Agency for International Development (USAID)
name: The Israeli National Institute for Health Policy Research
name: Maccabi Healthcare Services, Israel
First posted: 2017-02-27
Enrollment: 12800
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Child (age 0-5y) \& Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.

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).

Eligibility criteria: 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

Primary outcomes:
measure: S. pneumoniae carriage
timeFrame: 1 Day
Secondary outcomes:
measure: Carriage of Vaccine-type S. pneumoniae
timeFrame: 1 Day
measure: Carriage of antibiotic resistant S. pneumonia
timeFrame: 1 Day
measure: Carriage of piliated S. pneumonia
timeFrame: 1 Day
measure: Carriage of MRSA
timeFrame: 1 Day
measure: S. aureus carriage
timeFrame: 1 Day
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: IRB Committee Sheba Medical Center Israel
name: Dror Harats, Prof.
role: STUDY_CHAIR
References:
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.
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.
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.
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.