Status:
COMPLETED
Population Pharmacokinetic-pharmacodynamic (PK-PD) Study of 9 Broad-Spectrum Anti-infective Agents in the Cerebro Spinal Fluid (CSF) of Brain Injured Patients With an External Ventricular Drainage (EVD).
Lead Sponsor:
Poitiers University Hospital
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Nosocomial Central Nervous System infections are difficult to treat and an early appropriate therapy can improve prognosis. The two main reasons for treatments failure are the difficulty to reach high...
Eligibility Criteria
Inclusion
- Brain injury patients requiring intensive care management with external ventricular drainage
- Age ≥18 years old
- Patient with a CNS or other site infection treated with one or several of the ATB of the study
- Signed informed consent of the patient or the close friend / family after giving a clear and loyal information about the study
- Free subject, without guardianship or curatorship or subordination
- Patients benefiting from a Social Security system or benefiting from it through a third party
Exclusion
- Age under 18 years old
- Acute renal failure defined with a creatinine clearance \< 50 mL/min and / or under continuous haemodialysis
- Contraindication to the antibiotic studied
- No informed consent signed or no emergency procedure for continuous infusion antibiotic signed
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies.
- Pregnant or nursing women
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT03481569
Start Date
July 6 2018
End Date
July 6 2023
Last Update
July 10 2023
Active Locations (1)
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1
CHU of Poitiers
Poitiers, France, 86000