A -- Conduct Pharmacokinetic Studies of Oral Azithromycin in Infants less than 4 months old with C.trachomatis Pneumonia and Conjunctivitis

The National Institute of Child Health and Human Development (NICHD) under the authority of the The Best Pharmaceuticals Act (BPCA), has a requirement for a study of the pharmacokinetics (PK), safety and effectiveness of oral azithromycin for treatment of infants diagnosed with or at risk of being infected with Chlamydia trachomatis (C.trachomatis.) These Studies shall conform to the specifications that will be contained in the Request for Proposals (RFP) and the final protocol approved by the NICHD. These Studies shall also be required to conform to all applicable Food and Drug Administration (FDA) regulations for research conducted under an Investigational New Drug Application (IND.) The overall scope of this requirement will be to: (1) study oral azithromycin PK in infants less than four months of age who are diagnosed with C.trachomatis pneumonia or conjunctivitis, (2) determine the feasibility of a treatment study comparing the efficacy of azithromycin to erythromycin in this group of infants less than four months of age, and to (3) determine the feasibility of a prevention study comparing oral azithromycin to placebo in infants less than two weeks of age who are at risk of developing C.trachomatis infection. It is estimated that a minimum of 48 subjects may be required over a three-year period of performance to conduct the study. The Contractor will be required to enroll a minimum of 16 patients per year per dose level of oral azithromycin for the single and multiple dose PK studies in the infants less than four months of age who are diagnosed with C.trachomatis pneumonia or conjunctivitis. The results of the single and multiple dose PK Studies will be used to support the FDA pediatric labeling of oral azithromycin for C.trachomatis. In addition, the data provided will be used to derive PK information, safety and tolerability as set forth in the FDA Written Request that will be contained in the RFP. Currently, the NICHD has awarded contracts for several other BPCA drug studies, including a contract for a BPCA Coordinating Center. Additional information on BPCA and NICHD can be found at http://www.nichd.nih.gov/oppb/bpca/index.htm. THIS ANNOUNCEMENT IS NOT THE REQUEST FOR PROPOSALS. It is anticipated that the RFP will be issued on or about March 14, 2005. The proposals will be due 60 days after the issue date. Questions regarding this announcement should be directed to Paul J. Duska, Contracting Officer, Contracts Management Branch, OAM, NICHD, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, Maryland 20892-7510. All correspondence should cite the referenced RFP-NIH-NICHD-2005-14. Questions may also be directed by telephone +1 (555) 000-0000, FAX +1 (555) 000-0000 or email contact@example.gov. However, email is the preferred method and is considered to be the most expeditious.