To evaluate the pharmakcokinetics, tolerability and short term safety of ciprofloxacin in neonates and infants with suspected (or proven) Gram Negative Infection Open Label pilot PK study - TINN Treat Infections in Neonates Program(TINN-PK) - TINN Treat Infections in Neonates Pharmocokinetics of Ciprofloxaci
- Conditions
- Pharmacokinetics of ciprofloxacin used for suspected or proven gram negative sepsis.
- Registration Number
- EUCTR2010-019955-23-GB
- Lead Sponsor
- iverpool Women's NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Likely not to survive for more than 48 hours in judgement of attending physician.
Significant liver or renal impairment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method