This sub-study is led by Professor William Hope and Dr Kat Stott, and examines the pharmacokinetics and pharmacodynamics of liposomal amphotericin B, amphotericin B deoxycholate, flucytosine and fluconazole in clinical cryptococcal meningitis. Recruitment to the PK/PD sub-study is now complete; in total, 65 participants were enrolled from both arms of the AMBITION trial, at the Blantyre site only. Serial samples of blood (11 from each participant) and CSF (at least three from each participant) were taken on days 1, 7 and 14 from these participants.
This was a team effort, with all study clinicians working together in Blantyre to collect, document and process all of these samples in an accurate and timely manner. The samples have been analysed at the University of Liverpool, UK, and the data described using population pharmacodynamic modelling.