Investigating how anti-infectives work in critically ill children
Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children
This study is trying to see how different anti-infective medications work in critically ill children to help figure out the best doses for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT02539407 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the pharmacokinetics and pharmacodynamics of various anti-infectives in critically ill pediatric patients. By analyzing blood samples from children receiving these medications, the study seeks to identify how individual factors affect drug concentrations and clinical outcomes. The goal is to address the significant variability in drug response among critically ill children and to propose more personalized dosing regimens. The study will take place across six pediatric services in public hospitals in Paris, France.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill children who require the administration of specific anti-infectives during their hospitalization.
Not a fit: Patients whose parents refuse data recovery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for anti-infectives in critically ill children, potentially enhancing their clinical outcomes.
How similar studies have performed: While studies have shown variability in drug response in critically ill adults, this specific approach in critically ill children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minor patient requiring the administration of an anti-infective belonging to the following classes : β-lactam antibiotics; aminoglycosides, glycopeptides; fluoroquinolones; other antibiotics (daptomycin, rifampin, trimethoprim, sulfamethoxazole, clarithromycin); fungal; antivirals, during its follow-up or hospitalization Exclusion Criteria: * Patient and parents having notified to the doctor that they refuse data recovery.
Where this trial is running
Paris
- Hospital Necker - Enfants Malades (Public Hospitals of Paris) — Paris, France (Recruiting)
Study contacts
- Principal investigator: Oualha Mehdi, MD,PhD — Hospital Necker - Enfants Malades
- Study coordinator: Oualha Mehdi, MD,PhD
- Email: mehdi.oualha@nck.aphp.fr
- Phone: +33171196082
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.