This study describes audiologic methodology and results for evaluating potential ototoxicity
in a phase I clinical trial of a new glycopeptide. This study was conducted under
good clinical practices, which are regulated by the US Food and Drug Administration
(FDA) (21 Code of Federal Regulations), and input from the FDA was sought prior to
study implementation. Healthy, normal volunteers underwent extensive medical and audiologic
assessments as part of this phase I dose- escalation study of dalbavancin, a new glycopeptide,
to assess potential side effects. Audiologic monitoring included air-conduction thresholds
in the conventional (0.25-8 kHz) and high-frequency (10-16 kHz) ranges. At baseline,
subjects were also tested using word recognition, bone conduction testing if indicated,
and tympanometry. Full testing was to be repeated if any subject met the American
Speech-language-Hearing Association (ASHA) 1994 criteria for ototoxic change. However,
no subjects demonstrated ototoxic change after receiving dalbavancin, nor were any
false-positive results obtained.
Key Words
Audiologic monitoring - clinical trials - dalbavancin - glycopeptide - high-frequency
audiometry - ototoxicity monitoring - phase I - FDA
