Investigating how anti-infectives work in critically ill children
Official title: Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children
Run by Assistance Publique - Hôpitaux de Paris · NCT02539407 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Day to 18 Years |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | September 11, 2015 |
| Main results expected | October 2028 |
| Study ends | December 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT02539407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are critically ill children who require the administration of specific anti-infectives during their hospitalization.
✕Probably not a fit
Patients whose parents refuse data recovery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.