Can the dose of the polymyxin B antibiotic be optimised to be used in babies, children and adolescents?
What is the right dose of antibiotic polymxin B to give to babies, children and adolescents?
What is this study about?
Bacterial infection is one of the leading causes of death in children. Many bacterial organisms have developed resistance to multiple groups of antimicrobial agents. One group that causes some of the most concerning multi drug resistant infections are carbapenem resistant organisms (CROs). Since only a few new antibiotics are under development which are not currently available in all regions, there is an interest in optimising the use of older off patent antibiotics to treat infections such as polymyxin B which is active against CROs. Although polymyxin B is registered for use in adults, children and infants by the US Food and Drug Administration, there is limited evidence base for the recommended dose, particularly in children. The aim of this single dose PK and safety study is to identify the optimal dose to be taken forward into a polymyxin B multidose study as part of combination therapy for proven or suspected CRO infections and evaluate the safety of single dose.
Type of study
Who is funding the study?
When is it taking place?
2020 - 2023
Where is it taking place?
Italy and South Africa
Who is included?
Neonates, children and adolescents under 18 years of age