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B -- STUDY THE EFFECTS OF A FLUOROQUINOLONE ANTIBIOTIC ON A CHEMOSTAT MODEL SYSTEM SOL 262217-00-98 DUE 082698 POC Trudy Dartouzos, Contract Specialist, ph: 301-827-7165; fax: 301-827-7103 See Note #1. The Food and Drug Administration [FDA], intends to award a purchase order to TechLab to determine the concentration of a fluoroquinolone antibiotic that produces no adverse effect on the human intestinal microflora. The adverse effects to be evaluated shall be: 1) changes in the metabolic activity of the colonic flora; 2) development of antimicrobial resistant strains; 3) disruption of colonization resistance to pathogenic microorganisms; and 4) counts of target organisms. Low levels of a fluoroquinolone antibiotic shall be added to a stabilized continuouos chemostat model system. The system should have been previously inoculated with a suspension of human feces from healthy volunteers(s) that have not received antibiotic treatment for at least three (3) months. This project shall determine the lowest level of a flouroquinolone antibiotic that could perturb the intestinal microflora, especially in the ability to develop resistant strains. A final report including all results obtained from the different studies performed with a fluoroquinolone antibiotic in the chemostat system, as well as a report to include a summary of three (3) previous reports and an overall conclusion on the study. Written quotes required by 2:00 p.m., 8/26/98. Posted 08/10/98 (W-SN234852). (0222)

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