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

A -- EVALUATION OF DICHLOROACETATE (DCA) AS ADJUNCT THERAPY IN SEVERE MALARIA POC Sara Southard, Contract Specialist, (301) 402-6289, Carl Henn, Contracting Officer, (301) 496-0993 The National Institute of Allergy and Infectious Diseases, NIH, intends to negotiate with the University of Florida (Gainesville, FL) for a five (5) year contract which would support a masked, placebo controlled, phase III clinical trial of dichloroacetate (DCA) as adjunct therapy in the treatment of life-threatening cerebral malaria. The work to be conducted under this proposed contract will evaluate the efficacy of DCA in lowering lactic acid levels and reducing mortality in patients suffering from this disease. Authority: 41 U.S.C. 253(c)(1) as set forth in FAR 6.302.1. As a prerequisite for this phase III trial, the University of Florida and its collaborators have conducted, over the last three years, the necessary phase I/II studies on-site in Kumasi, Ghana. Based on the results of these preliminary investigations and the infrastructure that they have developed at the Kumasi site, these investigators and this site are uniquely qualified to conduct this trial. The site and its facilities will permit the recruitment of the required 1500 patients (ages 18 months to 12 years of age) and provide for the appropriate clinical management and evaluation of parasitological and biochemical tests required to be performed on study participants. Inherent duplication of cost to the Government, unacceptable delays in completing the project and the lack of any other known source having the requisite infrastructure and clinical populations to conduct this mortality study, make competition unfeasible. See Numbered Note 22.(0306)

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