APPA Neonatal and Paediatric Penicillins Study

• 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).; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002366-40-GB
• Lead Sponsor: St George’s, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified