Staphylococcus AureusNCT03064373
Mother to Newborn Transmission of Staphylococcus Aureus and Dynamics of S.Aureus Carriage During the First Years Life
An observational study of Staphylococcus Aureus, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Staphylococcus aureus (SA) is a significant cause of community and hospital acquired infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have been reported in very young infants and newborns. Read more about this study
- Who is it for?
- Ages 24 hours to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Dec 2008to 17 Jun 2023
- 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 24 hours to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 300 mother - newborn pairs.
Who may be able to join
- Gravid women expected to deliver within 4 weeks.
- Women who agree to participate and sign an informed consent
- Women who are S. aureus carriers at the time of recruit.
Who cannot join
- Prolonged (>6 days) newborn hospitalization.
- Women who did not give birth eventually at the Sheba Medical Center.
- Women who's newborns were not screened at least once during delivery hospitalization.
- Enrollment:
- 300 consecutive women who are defined as S. aureus carriers (see definitions below).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, Israel, 5265601
Gili Regev-Yochay, 0526666197
About this study
Official title: Mother to Newborn Transmission of Staphylococcus Aureus and the Dynamics of S. Aureus Carriage During the First Years of Life
Staphylococcus aureus (SA) is a significant cause of community and hospital acquired infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have been reported in very young infants and newborns. Previous studies have suggested that the source of SA carriage in young children is SA carried by their mothers. Possible modes of transmission from mother to child are transmission during passage through a colonized birth canal, through lactation and/or close contact.
We aim to 1) Define the route of transmission between mother and newborn. 2) Assess the dynamics of S. aureus carriage during the first years of life and specifically determine risk factors for becoming a persistent carrier of S. aureus
Read the detailed description
Design:
prospective cohort study which will examine the risk of exposure to S. aureus carrier mother on the outcome: S. aureus carriage by newborns following delivery and at discharge.
- Risk of vertical transmission during delivery will be assessed by comparing a cohort of newborns to vaginal S. aureus carrier mothers to a cohort of newborns of mothers not carrying S. aureus vaginally.
- Risk of horizontal transmission during the first days of life will be assessed by following a cohort of newborns not colonized on delivery day. The main exposure of interest is maternal nasal SA carriage.Target populations: 300 mother - newborn pairs.
Setting:
Sheba Medical Center obstetrical unit and nursery Gravid women will be recruited during antenatal visit at the Sheba medical Center, 1-4 weeks prior to labor. Women who will agree to participate and sign an informed consent will be screened for nasal and vaginal carriage of S. aureus. Newborns will be screened on delivery day and on discharge day.
Inclusion criteria:
- Gravid women expected to deliver within 4 weeks.
- Women who agree to participate and sign an informed consent
- Women who are S. aureus carriers at the time of recruit.
Exclusion criteria:
- Prolonged (>6 days) newborn hospitalization.
- Women who did not give birth eventually at the Sheba Medical Center.
- Women who's newborns were not screened at least once during delivery hospitalization.
Enrollment:
300 consecutive women who are defined as S. aureus carriers (see definitions below).
Screening will include:
Stage I before discharge:
- Women - nasal screenings:
- On recruitment day (~1-4 weeks before labor), B) During hospitalization for delivery. Vaginal screening will be performed during the routine gynecologic examination on delivery day.
- Newborns - will be screened A) On birth day, at entrance to the nursery. B) On discharge day. Screening will include nasal nares, umbilical, ear and rectal swabbing on each screening while hospitalized.
- Data collection by questionnaires filled by recruited women.
- Data collection from medical files of the maternity ward.
Stage II after discharge until age 5 years:
- Mothers - monthly nasal swab for 12 months.
- Children - monthly nasal, nasopharyngeal and rectal swabs for 12 months.
- Same screen annually until the child is 5years old.
- Data collection by questionnaires filled by the mothers.
- Conditions
- Staphylococcus Aureus
- Keywords
- S. aureus, carriage, mother-neonatal transmission, microbiome
- Medical subject headings
- Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
S. aureus carriage
Carriage of S. aurues in any of the sites
Measured: 5 years
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 start17 Dec 2008
- Primary completion17 Dec 2022 (estimated)
- Study completion17 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- The Israel Science Foundation
- Responsible party
- Principal investigator, Gili Regev-Yochay MD, Sheba Medical Center
- Investigators
- Dror Charats, Prof., Study chair, IRB Committee.Sheba Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064373
- Sponsor's protocol ID
- 5534-08
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leshem E, Maayan-Metzger A, Rahav G, Dolitzki M, Kuint J, Roytman Y, Goral A, Novikov I, Fluss R, Keller N, Regev-Yochay G. Transmission of Staphylococcus aureus from mothers to newborns. Pediatr Infect Dis J. 2012 Apr;31(4):360-3. doi: 10.1097/INF.0b013e318244020e.
PubMed 22189535
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
- Mother to Newborn Transmission of Staphylococcus Aureus and the Dynamics of S. Aureus Carriage During the First Years of Life
- ClinicalTrials.gov ID
- NCT03064373
- Acronym / sponsor ID
- 5534-08
- Conditions
- Staphylococcus Aureus
- Keywords
- S. aureus, carriage, mother-neonatal transmission, microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- The Israel Science Foundation
- Study start
- 17 Dec 2008 (actual)
- Primary completion
- 17 Dec 2022 (estimated)
- Study completion
- 17 Jun 2023 (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.
Staphylococcus aureus (SA) is a significant cause of community and hospital acquired infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have been reported in very young infants and newborns. Previous studies have suggested that the source of SA carriage in young children is SA carried by their mothers. Possible modes of transmission from mother to child are transmission during passage through a colonized birth canal, through lactation and/or close contact.
We aim to 1) Define the route of transmission between mother and newborn. 2) Assess the dynamics of S. aureus carriage during the first years of life and specifically determine risk factors for becoming a persistent carrier of S. aureus
Detailed description
Design:
prospective cohort study which will examine the risk of exposure to S. aureus carrier mother on the outcome: S. aureus carriage by newborns following delivery and at discharge.
- Risk of vertical transmission during delivery will be assessed by comparing a cohort of newborns to vaginal S. aureus carrier mothers to a cohort of newborns of mothers not carrying S. aureus vaginally.
- Risk of horizontal transmission during the first days of life will be assessed by following a cohort of newborns not colonized on delivery day. The main exposure of interest is maternal nasal SA carriage.Target populations: 300 mother - newborn pairs.
Setting:
Sheba Medical Center obstetrical unit and nursery Gravid women will be recruited during antenatal visit at the Sheba medical Center, 1-4 weeks prior to labor. Women who will agree to participate and sign an informed consent will be screened for nasal and vaginal carriage of S. aureus. Newborns will be screened on delivery day and on discharge day.
Inclusion criteria:
- Gravid women expected to deliver within 4 weeks.
- Women who agree to participate and sign an informed consent
- Women who are S. aureus carriers at the time of recruit.
Exclusion criteria:
- Prolonged (>6 days) newborn hospitalization.
- Women who did not give birth eventually at the Sheba Medical Center.
- Women who's newborns were not screened at least once during delivery hospitalization.
Enrollment:
300 consecutive women who are defined as S. aureus carriers (see definitions below).
Screening will include:
Stage I before discharge:
- Women - nasal screenings:
- On recruitment day (~1-4 weeks before labor), B) During hospitalization for delivery. Vaginal screening will be performed during the routine gynecologic examination on delivery day.
- Newborns - will be screened A) On birth day, at entrance to the nursery. B) On discharge day. Screening will include nasal nares, umbilical, ear and rectal swabbing on each screening while hospitalized.
- Data collection by questionnaires filled by recruited women.
- Data collection from medical files of the maternity ward.
Stage II after discharge until age 5 years:
- Mothers - monthly nasal swab for 12 months.
- Children - monthly nasal, nasopharyngeal and rectal swabs for 12 months.
- Same screen annually until the child is 5years old.
- Data collection by questionnaires filled by the mothers.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 hours to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 300 mother - newborn pairs.
Key inclusion criteria (3 listed)
- Gravid women expected to deliver within 4 weeks.
- Women who agree to participate and sign an informed consent
- Women who are S. aureus carriers at the time of recruit.
Key exclusion criteria (5 listed)
- Prolonged (>6 days) newborn hospitalization.
- Women who did not give birth eventually at the Sheba Medical Center.
- Women who's newborns were not screened at least once during delivery hospitalization.
- 300 consecutive women who are defined as S. aureus carriers (see definitions below).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
S. aureus carriage
Time frame: 5 years
Carriage of S. aurues in any of the sites
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 22189535Leshem E, Maayan-Metzger A, Rahav G, Dolitzki M, Kuint J, Roytman Y, Goral A, Novikov I, Fluss R, Keller N, Regev-Yochay G. Transmission of Staphylococcus aureus from mothers to newborns. Pediatr Infect Dis J. 2012 Apr;31(4):360-3. doi: 10.1097/INF.0b013e318244020e.
- 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.
Dror Charats, 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 Staphylococcus Aureus, 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 3 inclusion and 5 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 (052-6666197, 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. aureus carriage (time frame: 5 years). 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 NCT03064373, which also lists 1 linked publication.
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.