The ALPHA (AnaLysis of PHarmacokinetics of Amikacin) Study

Treatment of patients with multidrug-resistant TB (MDR-TB) is particularly challenging because of the frequency of side effects, the high cost and the long duration of treatment; the latter of which can be upwards of 24 months. Aminoglycosides (AGs), the cornerstone of MDR-TB treatment, often cause major side effects, such as hearing loss and kidney damage. Avoiding AG side effects is a crucial element of good treatment management and can be life-changing for patients. Though AGs have been potent components of antimicrobial regimes for decades little is known about how to best monitor treatment and minimize toxicities. Therefore we recently launched a study called AnaLysis of Pharmacokinetics of Amikacin or ALPHA. ALPHA is a prospective, observational pilot study recruiting patients at the National Tuberculosis Treatment Centre based at Mulago Hospital in Kampala, Uganda. It investigates the pharmacokinetics (PKs) of AGs and explores the relationship between PK values and AG related toxicities in patients receiving treatment for MDR-TB. 30 patients with confirmed multidrug-resistant (MDR) TB will be enrolled in the pilot study. The estimated study period is 12 months.