General guidelines for clinical bacteriology. Infectious Diseases Society of America and the Food and Drug Administration.
This guideline summarizes recommendations for (1) developing cogent procedures for diagnosis and antimicrobial susceptibility testing; (2) developing quality-control parameters for the microbiological components of clinical trials; (3) continually updating U.S. Food and Drug Administration (FDA) guidelines; (4) reviewing microbiological recommendations from other groups, such as Microbiology Subcommittees of the National Committee for Clinical Laboratory Standards; and (5) improving the microbiological aspects of FDA package inserts for antimicrobial drugs. Sensitive and specific methods for isolation and identification of pathogens are essential to the proper conduct of clinical trials. Susceptibility tests should be performed in an accurate and reproducible fashion. Verification of results in a reference laboratory is encouraged to monitor quality control.
Thrupp
L D
LD
Department of Medicine, University of California, Irvine, Orange 92668.
Cleeland
R
R
Jones
R N
RN
Novick
W J
WJ
Reller
L B
LB
Thornsberry
C L
CL
Washington
J A
JA
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001424:Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D001431:Bacteriological Techniques / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D004352:Drug Resistance, Microbial; D006801:Humans; D008826:Microbial Sensitivity Tests / Q000592:standards; D011786:Quality Control
D000900:Anti-Bacterial Agents