Multidrug Resistant Bacterial InfectionNEOBIOTANCT06391463
Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit
An observational study of Multidrug Resistant Bacterial Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection. Read more about this study
- Who is it for?
- Ages Up to 20 weeks
- Conditions the study is for
- Multidrug Resistant Bacterial Infection
- What is being tested?
- Carriage of MRB ou BC
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 1 Sep 2024
- 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 20 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Newborn hospitalized in the neonatology service of Croix Rousse hospital with at least one coproculture
Who may be able to join
- Children hospitalized in the department of neonatology at croix rousse university hospital
- With at least one coproculture
Who cannot join
- Death or discharge of the patient before the first stool culture has been taken
- Impossibility for the laboratory to interpret the stool culture in a patient in whom only one stool culture has been taken, or recurrence of impossibility to interpret all stool cultures from the same patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Presence of Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit: Implications for Practice
Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection.
The spread of MRBs is particularly prevalent in hospital units caring for fragile patients, such as neonatal units. Preventing the spread of MRBs is of prime importance in these units, in order to limit the number of infections caused by these germs. Newborns are at risk of infection due to intrinsic factors such as an immature immune system and fragile skin, as well as extrinsic factors such as mechanical ventilation and intravascular catheters.
Read more
In Germany, a 2012 KRINKO agreement encourages neonatal units to monitor MRB carriage on a weekly basis. This measure enables early detection of MRB colonization outbreaks in neonatal units. In France, MRB carriage monitoring in neonatal units is not systematic.
Spore-forming bacteria also require close monitoring in neonatology, as they do not strictly meet the definition of MRB, but represent a major threat to newborns. The main spore-forming bacterium of medical interest is Bacillus cereus (BC), which is responsible for serious infections in premature infants. BC is resistant to the use of hydro-alcoholic solutions. The origin of these BC infections remains controversial, with numerous studies in the international literature suggesting a link between BC infections and contamination of breast milk given to infants in neonatal units. The role of environmental contamination has also been studied. The potential seriousness of these BC infections justifies the systematic detection of the carriage of this spore-forming bacterium in routine coprocultures, in the same way as other MRB germs.
In the neonatal unit at Hôpital de la Croix Rousse, MRB and BC are routinely tested on patient arrival, and then weekly until discharge.
If MRB or BC germs are found in children's stools reinforced specific hygiene measures are implemented to prevent cross-transmission in this open-bay unit with little space between incubators. Reinforced specific hygiene measures represent a time constraint for the nursing team, for parents and a financial burden for the neonatal unit. However, to our knowledge, there are no international or national recommendations concerning the duration of stools reinforced specific hygiene measures. Our clinical experience has shown that the persistence of pathogenic germs in stools seems to vary in duration depending on the microorganism.
To better determine the optimal duration of reinforced specific hygiene measures, as it is costly in terms of work time, parental stress, and hospital expenses due to reinforced hygiene conditions during the isolation period.
- Conditions
- Multidrug Resistant Bacterial Infection
- Being tested
- Carriage of MRB ou BC
- Keywords
- multidrug-resistant bacteria, neonatology, spore-forming bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriage of MRB ou BCOther
Study of the epidemiology of the carriage of BMR and BC germs in patients in the neonatology department
| Study group | Role | What they receive |
|---|---|---|
| infants admitted in the neonatal unit of croix rousse hospital | Infant born between January 1, 2018 and September 27, 2020, admitted in the neonatology department of the Croix Rousse hospital who had at least one coproculture during their stay Receives: Other: Carriage of MRB ou BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of patients carrying BMR and BC germs
Determine the number of patients carrying BMR and BC germs
Measured: up to 4 months postnatal age or discharge which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391463
- Sponsor's protocol ID
- 23-5224
- Acronym
- NEOBIOTA
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Presence of Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit: Implications for Practice
- ClinicalTrials.gov ID
- NCT06391463
- Acronym / sponsor ID
- NEOBIOTA / 23-5224
- Conditions
- Multidrug Resistant Bacterial Infection
- Keywords
- multidrug-resistant bacteria, neonatology, spore-forming bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Apr 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.
Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection.
The spread of MRBs is particularly prevalent in hospital units caring for fragile patients, such as neonatal units. Preventing the spread of MRBs is of prime importance in these units, in order to limit the number of infections caused by these germs. Newborns are at risk of infection due to intrinsic factors such as an immature immune system and fragile skin, as well as extrinsic factors such as mechanical ventilation and intravascular catheters.
In Germany, a 2012 KRINKO agreement encourages neonatal units to monitor MRB carriage on a weekly basis. This measure enables early detection of MRB colonization outbreaks in neonatal units. In France, MRB carriage monitoring in neonatal units is not systematic.
Spore-forming bacteria also require close monitoring in neonatology, as they do not strictly meet the definition of MRB, but represent a major threat to newborns. The main spore-forming bacterium of medical interest is Bacillus cereus (BC), which is responsible for serious infections in premature infants. BC is resistant to the use of hydro-alcoholic solutions. The origin of these BC infections remains controversial, with numerous studies in the international literature suggesting a link between BC infections and contamination of breast milk given to infants in neonatal units. The role of environmental contamination has also been studied. The potential seriousness of these BC infections justifies the systematic detection of the carriage of this spore-forming bacterium in routine coprocultures, in the same way as other MRB germs.
In the neonatal unit at Hôpital de la Croix Rousse, MRB and BC are routinely tested on patient arrival, and then weekly until discharge.
If MRB or BC germs are found in children's stools reinforced specific hygiene measures are implemented to prevent cross-transmission in this open-bay unit with little space between incubators. Reinforced specific hygiene measures represent a time constraint for the nursing team, for parents and a financial burden for the neonatal unit. However, to our knowledge, there are no international or national recommendations concerning the duration of stools reinforced specific hygiene measures. Our clinical experience has shown that the persistence of pathogenic germs in stools seems to vary in duration depending on the microorganism.
To better determine the optimal duration of reinforced specific hygiene measures, as it is costly in terms of work time, parental stress, and hospital expenses due to reinforced hygiene conditions during the isolation period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants admitted in the neonatal unit of croix rousse hospital | – | Other: Carriage of MRB ou BCInfant born between January 1, 2018 and September 27, 2020, admitted in the neonatology department of the Croix Rousse hospital who had at least one coproculture during their stay |
Who may qualify
- Ages
- Up to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn hospitalized in the neonatology service of Croix Rousse hospital with at least one coproculture
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Carriage of MRB ou BCStudy of the epidemiology of the carriage of BMR and BC germs in patients in the neonatology department | Other | infants admitted in the neonatal unit of croix rousse hospital |
Primary outcome
Determine the number of patients carrying BMR and BC germs
Time frame: up to 4 months postnatal age or discharge which comes first
Determine the number of patients carrying BMR and BC germs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multidrug Resistant Bacterial Infection, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 30 Apr 2024. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of patients carrying BMR and BC germs (time frame: up to 4 months postnatal age or discharge which comes first). It is what the study was designed to measure, not a finding.
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 30 Apr 2024.