Observational study on resistant bacteria in children in France
National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
This study looks at how new antibiotics are used to treat infections in children with tough-to-treat bacteria to see if they are the right choice and to understand the effects of antibiotic resistance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06036628 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter, and prospective study aims to monitor the use of new antibiotics in pediatric patients suffering from infections caused by multi-resistant bacteria. The study evaluates the appropriateness of prescribing these new antibiotics based on the antibiogram of isolated bacteria or in cases where bacteriological documentation is lacking. It will also describe the clinical and biological characteristics of the participating children to better understand the impact of antibiotic resistance in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who are hospitalized in France and treated with specific new antibiotics for documented infections.
Not a fit: Patients who are not hospitalized or do not have infections caused by multi-resistant bacteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for pediatric infections caused by resistant bacteria, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in monitoring antibiotic use and resistance patterns, indicating that this approach is supported by previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil
- Activ — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Cohen Robert — Association Clinique Thérapeutique Infantile du val de Marne
- Study coordinator: Levy Corinne
- Email: corinne.levy@activ-france.fr
- Phone: 1 48 85 04 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.