Streptococcus PneumoniaePICRcarriageNCT03064620
PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
An observational study of Streptococcus Pneumoniae, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- PCV
- How many people
- 12,800 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Child (age 0-5y) \& Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.
Who may be able to join
- Any child younger than 5 years, visiting the participating clinics during the surveillance period
Who cannot join
- Older than 5 years
- Previously participated in the study.
- Sibling has participated in the study.
- Parent does not agree to sign informed consent
Trial locations and contacts
1 site in 1 country.
Ziad Abdeen, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, Israel, 5265601
Gili Regev-Yochay, 0526666197
About this study
Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:
- To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.
- 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.
Read the 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:
- Parent signs informed consent
- Put Barcode stickers on informed consent, questionnaire, swabs and daily list
- Fill questionnaire with parent.
- Fill physician questionnaire
- Nasal \& nasopharyngeal swab of child and parent.
- Fill daily working table.
- Write the number of refusals (parents who refused) on daily table.
- Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO.
Swabbing:
- First swab the child and then follow with the parent.
- 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).
- Slightly wet the nasal swab with sterile saline. Swab both anterior nares.
- 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).
- Conditions
- Streptococcus Pneumoniae
- Being tested
- PCV
- Keywords
- PCV effects, S. pneumoniae carriage, S. aureus carriage, Indirect vaccination effects, Palestinian-Israeli Collaborative Research (PICR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCVBiological
Also called PCV7, PCV10, PCV13
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: PCV | |
| 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. Receives: Biological: PCV | |
| 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. Receives: Biological: PCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. pneumoniae carriage
- pneumoniae carriage of children and parents by the different groups
Measured: 1 Day
Secondary outcomes (5)
Carriage of Vaccine-type S. pneumoniae
Carriage of Vaccine-type S. pneumoniae in children and parents by the different groups
Measured: 1 Day
Carriage of antibiotic resistant S. pneumonia
Carriage of antibiotic resistant S. pneumonia in children and parents by the different groups
Measured: 1 Day
Carriage of piliated S. pneumonia
Carriage of piliated S. pneumonia in children and parents by the different groups
Measured: 1 Day
Carriage of MRSA
Carriage of MRSA in children and parents by the different groups
Measured: 1 Day
S. aureus carriage
- aureus carriage of children and parents by the different groups
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startApr 2014
- Primary completionAug 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Streptococcus PneumoniaeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 12,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Palestinian-Israeli Collaborative Research (PICR), United States Agency for International Development (USAID), The Israeli National Institute for Health Policy Research, Maccabi Healthcare Services, Israel
- Responsible party
- Principal investigator, Gili Regev-Yochay MD, Sheba Medical Center
- Investigators
- Dror Harats, Prof., Study chair, IRB Committee Sheba Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064620
- Sponsor's protocol ID
- 8024-10
- Acronym
- PICRcarriage
- Status last verified
- Feb 2017
- First submitted
- 29 Mar 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25593104Southern 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.
PubMed 26245327Regev-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.
PubMed 22539955Biber 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.
PubMed 22916171
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study
- ClinicalTrials.gov ID
- NCT03064620
- Acronym / sponsor ID
- PICRcarriage / 8024-10
- Conditions
- Streptococcus Pneumoniae
- Keywords
- PCV effects, S. pneumoniae carriage, S. aureus carriage, Indirect vaccination effects, Palestinian-Israeli Collaborative Research (PICR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,800 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Palestinian-Israeli Collaborative Research (PICR), United States Agency for International Development (USAID), The Israeli National Institute for Health Policy Research, Maccabi Healthcare Services, Israel
- Study start
- Apr 2014
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:
- To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.
- 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:
- Parent signs informed consent
- Put Barcode stickers on informed consent, questionnaire, swabs and daily list
- Fill questionnaire with parent.
- Fill physician questionnaire
- Nasal \& nasopharyngeal swab of child and parent.
- Fill daily working table.
- Write the number of refusals (parents who refused) on daily table.
- Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO.
Swabbing:
- First swab the child and then follow with the parent.
- 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).
- Slightly wet the nasal swab with sterile saline. Swab both anterior nares.
- 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).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Israel PCV13 | – | Biological: PCVChildren 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 | – | Biological: PCVChildren 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 | – | Biological: PCVChildren 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Child (age 0-5y) \& Parent who attend pediatric clinics (for any reason), in the participating clinics during the surveillance periods.
Key inclusion criteria (1 listed)
- Any child younger than 5 years, visiting the participating clinics during the surveillance period
Key exclusion criteria (4 listed)
- Older than 5 years
- Previously participated in the study.
- Sibling has participated in the study.
- Parent does not agree to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCVAlso: PCV7, PCV10, PCV13PCV7 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 | Biological | East Jerusalem PCV13, Israel PCV13, Palestine PCV7 PCV10 |
Primary outcome
S. pneumoniae carriage
Time frame: 1 Day
S. pneumoniae carriage of children and parents by the different groups
5 secondary outcomes
Carriage of Vaccine-type S. pneumoniae
Time frame: 1 Day
Carriage of antibiotic resistant S. pneumonia
Time frame: 1 Day
Carriage of piliated S. pneumonia
Time frame: 1 Day
Carriage of MRSA
Time frame: 1 Day
S. aureus carriage
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 25593104Daana 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.
- Background: PubMed 26245327Southern 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.
- Background: PubMed 22539955Regev-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.
- Background: PubMed 22916171Biber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Abdeen, PhD contact
Dror Harats, Prof. study chair
IRB Committee Sheba Medical Center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gili Regev-Yochay, MD (0526666197, gili.regev.y@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S. pneumoniae carriage (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064620, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.