PK Unit
Our inpatient facility is situated on the lower ground floor at the UCT Lung Institute. The unit has a 10 bed capacity with a patient area including a lounge, bathrooms and a kitchenette. The unit is fully equipped for conducting Phase II and Phase III clinical trials with BP monitors, thermometers, glucometers, scales and other essential equipment. An emergency trolley with defibrillator, oxygen, and saturation monitoring is available. The facility also has a laboratory, geared for handling high throughput clinical trial samples with a refrigerated centrifuge and on site -80º freezing available.
The unit was established in 2006 and has developed an internationally recognized expertise in conducting Early Bactericidal Activity (EBA) studies in tuberculosis. Patients are admitted to the facility for studies of up to 14 days and are medically monitored on new treatments for safety and efficacy. A number of new drugs in the Phase II clinical development pipeline for tuberculosis have been trialed at this facility. These drugs have included new compounds such as PA 824, TMC-207 (Bedaquiline), SQ-109, Sutezolid and Delamanid. EBA studies of newer generation combinations of both new and existing anti- tuberculosis drugs are currently under investigation in the facility.
Over time as new drugs in tuberculosis have developed the need arose to develop the inpatient EBA studies into longer outpatient sputum conversion studies. To do this we have added an additional ventilated three room outpatient facility with the required study staff. This facility is also suitable for conducting vaccine and HIV studies.