Pharmacokinetic/Pharmacodynamics study of teicoplanin in children

• Research type

  Research Study

• Full title

  Liverpool Pharmacokinetic/pharmacodynamics study of teicoplanin in children (LIPSTIC).

• IRAS ID

  120870

• Contact name

  Stephane Paulus

• Eudract number

  2012-005738-12

• Research summary

  In the paediatric population, there is often suboptimal drug dosage information that does not take into account the changes in how the body handles drugs across childhood. This may lead to drug-related toxicity or ineffective treatment with the subsequent potential for developing microbial resistance. Current teicoplanin dosage recommendations in children are outdated and are based on simplified approaches using the established dose for adults together with scarce data from children and neonates. This study aims to evaluate data on how teicoplanin is handled across childhood and pilot data about which serum levels are related to better clinical outcomes. This will contribute to an optimal evidence-based dosage regimen.Teicoplanin is an antimicrobial with activity against Gram-positive bacteria similar to that of vancomycin, adding a better safety profile and ease of administration. Resistance to vancomycin has been found in most commonly occurring, clinically significant Gram-positive bacterial species. Therefore, there is a renewed interest in evaluating the optimal use and activity of teicoplanin. Appropriate dosing would lead to shorter treatments, shorter hospital stays, increased survival and reduced morbidity in both neonates and children. Neonates and children up to 16 years old hospitalised at The Liverpool Women??s Hospital and Alder Hey Children??s Hospital, and treated with teicoplanin as part of their routine clinical care will be eligible for the study. Each participant will be in the study for the duration of their teicoplanin treatment and blood samples will be taken for teicoplanin levels at the same time as routine blood samples and at other times. In addition, DNA sampling will be performed if consented in order to analyse further genotypic influences to body drug handling.The amount of teicoplanin needed to stop Gram positive bacteria from growing will also be recorded for all such bacteria isolated at either hospital.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0023

• Date of REC Opinion

  27 Mar 2013

• REC opinion

  Further Information Favourable Opinion