TY - JOUR
T1 - Audiologic monitoring for potential ototoxicity in a phase I clinical trial of a new glycopeptide antibiotic
AU - Campbell, Kathleen C.M.
AU - Kelly, Ellen
AU - Targovnik, Nan
AU - Hughes, Larry
AU - Van Saders, Claudia
AU - Gottlieb, Alice Bendix
AU - Dorr, Mary Beth
AU - Leighton, Anton
N1 - Funding Information:
Acknowledgement. This study was funded by Vicuron Pharmaceuticals.
PY - 2003
Y1 - 2003
N2 - This study describes audio logic 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.
AB - This study describes audio logic 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.
KW - Audiologic monitoring
KW - Clinical trials
KW - Dalbavancin
KW - FDA
KW - Glycopeptide
KW - High-frequency audiometry
KW - Ototoxicity monitoring
KW - Phase I
UR - http://www.scopus.com/inward/record.url?scp=0141991789&partnerID=8YFLogxK
M3 - Article
C2 - 12859140
AN - SCOPUS:0141991789
SN - 1050-0545
VL - 14
SP - 157
EP - 168
JO - Journal of the American Academy of Audiology
JF - Journal of the American Academy of Audiology
IS - 3
ER -