the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICUNEOSAURNCT06267352
Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology
An observational study of the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU, run by University Hospital, Caen.
Trial summary
Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MSSA carrier among newborns hospitalized in neonatal ICU
Who may be able to join
- newborns hospitalized in neonatal ICU
- MSSA carrier
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiology and Genomic Surveillance of Methicillin-sensitive Staphylococcus Aureus in ICU Neonatology : Rectal and Nasal Screening, Cross Transmission and Decolonisation
Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.
In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.
Read more
Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.
With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing
- the epidemiology of MSSA carriage and infections
- cross-transmission of MSSA strains between patients
- the success rate of decolonization
- the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns.
- Keywords
- cross-transmission, prevention and infection control, bacterial typing
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of MSSA cross transmission as assessed by WGS
Number of patients with acquired MSSA / total number of MSSA carriers
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (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 the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICUStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267352
- Sponsor's protocol ID
- 230097
- Acronym
- NEOSAUR
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akinboyo IC, Zangwill KM, Berg WM, Cantey JB, Huizinga B, Milstone AM. SHEA neonatal intensive care unit (NICU) white paper series: Practical approaches to Staphylococcus aureus disease prevention. Infect Control Hosp Epidemiol. 2020 Nov;41(11):1251-1257. doi: 10.1017/ice.2020.51. Epub 2020 Sep 14. No abstract available.
PubMed 32921340
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Genomic Surveillance of Methicillin-sensitive Staphylococcus Aureus in ICU Neonatology : Rectal and Nasal Screening, Cross Transmission and Decolonisation
- ClinicalTrials.gov ID
- NCT06267352
- Acronym / sponsor ID
- NEOSAUR / 230097
- Keywords
- cross-transmission, prevention and infection control, bacterial typing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.
In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.
Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.
With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing
- the epidemiology of MSSA carriage and infections
- cross-transmission of MSSA strains between patients
- the success rate of decolonization
- the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MSSA carrier among newborns hospitalized in neonatal ICU
Key inclusion criteria (2 listed)
- newborns hospitalized in neonatal ICU
- MSSA carrier
Key exclusion criteria (1 listed)
- none
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
frequency of MSSA cross transmission as assessed by WGS
Time frame: Month 24
Number of patients with acquired MSSA / total number of MSSA carriers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 32921340Akinboyo IC, Zangwill KM, Berg WM, Cantey JB, Huizinga B, Milstone AM. SHEA neonatal intensive care unit (NICU) white paper series: Practical approaches to Staphylococcus aureus disease prevention. Infect Control Hosp Epidemiol. 2020 Nov;41(11):1251-1257. doi: 10.1017/ice.2020.51. Epub 2020 Sep 14. No abstract available.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU, run by University Hospital, Caen.
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 2 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 20 Feb 2024. 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?
Contact Camille JEANNE-LEROYER (0231065947, jeanneleroyer-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of MSSA cross transmission as assessed by WGS (time frame: Month 24). 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 NCT06267352, 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 20 Feb 2024.