National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- CHRONIC LYME BORRELIOSIS CLINICAL TRIAL SOL N01-AI-65296 DUE 110498 POC Mr. Carl Henn, Contracting Officer, 301-496-0993 The National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases, is seeking sources capable of conducting randomized, placebo-controlled, double-blind clinicals trials to demonstrate the efficacy of treatment with intravenous ceftriaxone (2 grams per day for 30 consecutive days) followed by oral doxycycline (200 mg per day for 60 consecutive days) for the treatment of chronic Lyme borreliosis. The trials will involve defined cohorts of patients, from regions of the United States in which Lyme disease is endemic, that are either seropositive or seronegative for Lyme disease (by the two-test CDC-Dearborn criteria) at the time of enrollment, and who meet the inclusion and exclusion criteria established and approved for this study. Primary analysis of the efficacy of the antibiotic therapy used will be determined by improvement in the patient's health-related quality of life, as measured by the SF-36 Health Survey; it includes eight multi-item scales that measure physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Three additional multi-item scales from the medical outcomes study (MOS) will be used to measure cognitive functioning, pain, and role functioning; however, they will not be used for primary analysis of efficacy. The SF-36 Health Survey (and additional MOS measures) will be administered to study participants five times: at baseline (prior to therapy); at one month (the end of intravenous therapy); at three months (the end of intravenous and oral therapy); at six months; and at one year . Also, at baseline and at defined intervals (as stipulated in the protocol approved for use in these studies), specimens will be collected to test for: (a) an immune response to Borrelia burgdorferi antigens in serum and cerebrospinal fluid (CSF); (b) B. burgdorferi DNA in CSF; (c) viable B. burgdorferi in CSF; (d) B. burgdorferi antigens in urine; and (e) serum antibodies specific for possible co-infecting agents, e.g., Babesia microti and Ehrlichia species. Interested parties should submit, no later than November 4, 1998, four (4) copies of a capability statement addressing each of the areas outlined above. The statement also should include information on numbers of eligible volunteers likely to be enrolled per year (do not provide the names of prospective volunteers or personal identifiers). A copy of the specific inclusion and exclusion criteria approved for the study will be provided on request. This Sources Sought Announcement is a request for information to assist the NIAID in selecting additional sites for conducting the studies described. It may or may not result in a solicitation. Respondants are invited to discuss additional terms or conditions with the NIAID by contacting: Carl Henn Contracting Officer Contract Management Branch National Institute of Allergy & Infectious Diseases National Institutes of Health Solar Building, Room 3C02 6004 Executive Blvd., MSC 7630 Bethesda, MD20892-7630 Telephone: (301) 496-0993 FAX: (301) 480-5253 E-mail: ch24v@nih.goc Posted 10/07/98 (W-SN259961). (0280)

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