Infants With Positive GBS BacteremiaNCT00326313
Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study
An observational study of Infants With Positive GBS Bacteremia, run by Sheba Medical Center.
Trial summary
Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies. Read more about this study
- Who is it for?
- Ages 0 years to 2 weeks
- Conditions the study is for
- Infants With Positive GBS Bacteremia
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to not given
- 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 0 years to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GBS positive blood culture neonate and preterm babies
Who cannot join
- Congenital malformations
About this study
Official title: Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study
Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.
During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.
Read the detailed description
This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.
- Conditions
- Infants With Positive GBS Bacteremia
- Keywords
- Group B streptococci, virulent, morbidity, mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants With Positive GBS BacteremiaStudies 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
- Enrolment
- 74 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Tzipora Strauss, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326313
- Sponsor's protocol ID
- SHEBA-06-4132-TS-CTIL
- Status last verified
- May 2006
- First submitted
- 14 May 2006
- Last updated
- 16 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study
- ClinicalTrials.gov ID
- NCT00326313
- Acronym / sponsor ID
- SHEBA-06-4132-TS-CTIL
- Conditions
- Infants With Positive GBS Bacteremia
- Keywords
- Group B streptococci, virulent, morbidity, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2006
- First posted
- 16 May 2006 (estimated)
- 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.
Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.
During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.
Detailed description
This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.
Study design
Who may qualify
- Ages
- 0 years to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- GBS positive blood culture neonate and preterm babies
Key exclusion criteria (1 listed)
- Congenital malformations
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2006.
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.
Tzipora Strauss, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Infants With Positive GBS Bacteremia, run by Sheba Medical Center.
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 1 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 16 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 May 2006; AzTrials last refreshed its copy on 8 Nov 2026.