Resistant Bacteria in Children in France (NCT06036628) | Clinical Trial Compass
CompletedNot Applicable
Resistant Bacteria in Children in France
France306 participantsStarted 2023-04-01
Plain-language 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
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* Refusal of participation by the patient or his/her parent
* Medical history of mucoviscidosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relevance of prescribing "new antibiotics" according to patient status
Timeframe: 1 year
2
Relevance of prescribing "new antibiotics"
Timeframe: 1 year
Trial details
NCT IDNCT06036628
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne