Infection Due to Resistant BacteriaBREFNCT06036628
Resistant Bacteria in Children in France
An observational study of Infection Due to Resistant Bacteria and Multi-antibiotic Resistance, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Infection Due to Resistant Bacteria, Multi-antibiotic Resistance, Antibiotic Prescription
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 19 Dec 2025
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics
Who may be able to join
- Children under 18 years of age
- Hospitalized in France in a hospital center working with the ACTIV/GPIP network
- Treated with one or more of the following antibiotics:
- Colimycin (Colistimethate sodium)
- Cefiderocol
- Aztreonam in combination
Show all 30Show fewer
- Ceftolozane-Tazobactam
- Ceftazidime-avibactam
- Meropenem/vaborbactam
- Imipenem/Relebactam
- Tigecycline
- Daptomycin
- Ceftaroline fosamil
- Tedizolid phosphate
- Fidaxomicin
- Ceftobiprole
- Dalbavancin
- In association with a documented infection performed by:
- Blood culture
- Normally sterile site
- Cerebrospinal fluid
- Pleural fluid
- Pleura
- Peritoneum
- Joint fluid
- Other
- Urine sampling if the bacteria was considered responsible for the infection (associated with a leukocyturia ≥10,0000)
- Respiratory specimens if the bacteria was considered responsible for the infection
- Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous System (CNS),....
- Related to colonization with multidrug-resistant bacteria without documentation.
Who cannot join
- Refusal of participation by the patient or his/her parent
- Medical history of mucoviscidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria
Read the detailed description
The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
As this is a surveillance study, the clinical and biological characteristics of the children included will be described.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevance of prescribing "new antibiotics" according to patient status
Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
Measured: 1 year
Relevance of prescribing "new antibiotics"
how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria
Measured: 1 year
Secondary outcomes (7)
Describe Bacterial epidemiology of infections associated with prescription of new antibiotics
Characteristic of bacteria associated with prescription of new antibiotics
Measured: 1 year
Identify Risks factors for multi-resistant bacteria
Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,
Measured: 1 year
Describe Context of drug Prescription
How antibiotics medical prescriptions are controlled and validated
Measured: 1 year
Department involved in medical prescribing
Number of department involved in medical prescriptions
Measured: 1 year
Describe Associated Antibiotherapies type
Type of drug association prescribed
Measured: 1 year
Describe Associated Antibiotherapies
Number of drug association prescribed
Measured: 1 year
Describe patients outcome
Proportion of patients clinically and bacteriologically recovered
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Apr 2023
- Primary completion31 Oct 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Resistant BacteriaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Levy Corinne, Study director, Association Clinique Thérapeutique Infantile du val de MarneCohen Robert, Principal investigator, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036628
- Sponsor's protocol ID
- BREF
- Acronym
- BREF
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
- ClinicalTrials.gov ID
- NCT06036628
- Acronym / sponsor ID
- BREF / BREF
- Conditions
- Infection Due to Resistant Bacteria, Multi-antibiotic Resistance, Antibiotic Prescription, Risk Factors, Healing, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 14 Sep 2023 (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.
This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria
Detailed description
The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
As this is a surveillance study, the clinical and biological characteristics of the children included will be described.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics
Key inclusion criteria (30 listed)
- Children under 18 years of age
- Hospitalized in France in a hospital center working with the ACTIV/GPIP network
- Treated with one or more of the following antibiotics:
- Blood culture
- Normally sterile site
Key exclusion criteria (2 listed)
- Refusal of participation by the patient or his/her parent
- Medical history of mucoviscidosis
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
Relevance of prescribing "new antibiotics" according to patient status
Time frame: 1 year
Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
Relevance of prescribing "new antibiotics"
Time frame: 1 year
how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria
7 secondary outcomes
Describe Bacterial epidemiology of infections associated with prescription of new antibiotics
Time frame: 1 year
Identify Risks factors for multi-resistant bacteria
Time frame: 1 year
Describe Context of drug Prescription
Time frame: 1 year
Department involved in medical prescribing
Time frame: 1 year
Describe Associated Antibiotherapies type
Time frame: 1 year
Describe Associated Antibiotherapies
Time frame: 1 year
Describe patients outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
Levy Corinne study director
Association Clinique Thérapeutique Infantile du val de Marne
Cohen Robert principal investigator
Association Clinique Thérapeutique Infantile du val de Marne
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 Infection Due to Resistant Bacteria and Multi-antibiotic Resistance, run by Association Clinique Thérapeutique Infantile du val de Marne 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 30 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: finished, as of the sponsor's last update on 19 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relevance of prescribing "new antibiotics" according to patient status (time frame: 1 year). The study lists 2 primary outcomes in all. 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 19 Mar 2026.