The antimicrobial activity of ceftibuten, a new oral cephalosporin, was evaluated using 4735 clinical bacterial isolates processed at four medical centers. Ceftibuten inhibited nearly 92% of all Enterobacteriaceae (less than or equal to 8.0 micrograms/ml), thereby being markedly superior to cefixime which inhibited 78.7% at less than or equal to 1.0 microgram/ml and cefuroxime which inhibited 45.1% at less than or equal to 2.0 micrograms/ml. Pseudomonads and staphylococci were not within the spectrum of activity of ceftibuten. Ceftibuten was found to be very stable in the presence of five commonly occurring beta-lactamases of both the chromosomal-mediated (P99, K1) and plasmid-mediated (CARB-2, OXA-1, TEM-1) types. Only Type Ia (P99) beta-lactamase was significantly inhibited by ceftibuten. On the basis of results of a ceftibuten MIC quality control study conducted in five laboratories, a quality control range of 0.12 to 0.5 microgram/ml is recommended for the Escherichia coli ATCC 25922 strain.