EUCTR2013-002366-40-GB
Active, not recruiting
Not Applicable
eonatal and Paediatric Pharmacokinetics of Antimicrobials study - NAPPA (version 1.0)
ConditionsThe study is not restricted to any specific condition. The study population will include children (aged under 16 years) admitted to hospital and routinely prescribed one of the study penicillins according to local hospital policy for any indication (including medical or surgical prophylaxis).Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The study is not restricted to any specific condition. The study population will include children (aged under 16 years) admitted to hospital and routinely prescribed one of the study penicillins according to local hospital policy for any indication (including medical or surgical prophylaxis).
- Sponsor
- St George’s, University of London
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care.
- •2\. Informed consent form signed by parent or legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •1\. Any child or infant unlikely to survive 48 hours after recruitment.
- •2\. Patient known to be pregnant.
- •3\. Known allergy or hypersensitivity to beta\-lactam antibiotics (including penicillins and cephalosporins) or beta\-lactamase inhibitors.
- •4\. Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, ECMO (extracorporeal membrane oxygenation) or cardiopulmonary bypass.
Outcomes
Primary Outcomes
Not specified
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