Pharmacokinetics of ciprofloxacin used for suspected or proven gram negative sepsis.
Conditions
Interventions
Trade Name: Ciprofloxacin
Product Name: Ciprofloxacin
Pharmaceutical Form: Injection*
Sponsors
Liverpool Women's NHS Foundation Trust
Liverpoool Womens NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Neonates and infants 24 - 52 weeks gestation who are receiving ciprofloxacin following a clinical decision by their attending physician to treat suspected or proven sepsis. Parental consent to participate Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Likely not to survive for more than 48 hours in judgement of attending physician. Significant liver or renal impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop a population pharmacokinetic model for ciprofloxacin in preterm and term neonates, and infants up to the age of 3 months. The model will account for the age of the baby (including prematurity) and how well the kidneys are working. ;Secondary Objective: Adverse event 'side effect' monitoring to examine whether the medicine is well-tolerated by babies. Do any genetic factors predict how babies deal with ciprofloxacin?;Primary end point(s): Population pharmacokinetic model of ciprofloxacin in neonates and infants < 3 months of age. | — |
Countries
United Kingdom
Outcome results
None listed