SOLICITATION NOTICE
A -- CLINCIAL TRIAL FOR COMMUNITY-ACQUIRED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (CA-MRSA) INFECTIONS
- Notice Date
- 3/30/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DMID-07-12
- Response Due
- 8/15/2006
- Archive Date
- 8/30/2006
- Description
- The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) supports research to understand, and ultimately prevent and/or treat, infectious and immune-mediated diseases that continue to threaten millions of lives each year. The Government has a requirement to design and conduct a multi-site Phase II/III clinical trial for Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). NIAID intends to solicit this project utilizing full and open competitive procedures under NAICS 541710. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 5-year period of performance beginning on or about June 15, 2007. The objective of a contract will be to advance the field of clinical management for uncomplicated skin and soft tissue infection caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) and to determine the optimal outpatient treatment strategy. If selected the contractor would be expected to provide the scientific, technical, and managerial infrastructure, facilities, and other resources required to design and conduct a multi-site Phase II/III clinical trial. In addition, the contractor must have the ability to determine the efficacy of off-patent oral antimicrobials and/or wound care for the treatment of outpatients with uncomplicated community-acquired skin and soft tissue infection in areas in the U.S, where the prevalence of CA-MRSA is high. An uncomplicated skin and soft tissue infection is defined as the presence of wound infection, abscesses, folliculitis, cellulitis or erysipelas. Community-acquired methicillin-resistant Staphylococcus aureus infections are defined as the isolation of methicillin-resistant Staphylococcus aureus from the relevant disease process from subjects who have not been hospitalized within the previous fourteen (14) days. In order to preserve the efficacy of vancomycin and linezolid, evaluation of these two antimicrobials would not be supported under this effort. In addition, clinical trials of invasive diseases (e.g., bacteremia, endocarditis, osteomylitis or pneumonia) or clinical trials with hospitalized patients would not be supported under this contract. Clinical trials under this effort would require a minimum of two (2) and a maximum of five (5) clinical trial sites. Each clinical trial site, included would also be required to have access to one hundred and twenty (120) subjects with skin and soft tissue infection every three (3) months to ensure enrollment of a minimum of forty (40) subjects every three (3) months. It is estimated that a total effort of approximately 9.65 FTEs per year will be needed to accomplish this project. This RFP will be available electronically on/about April 15, 2006, and may be accessed through the NIAID Contract Management Program (CMP) Home Page at http://www.niaid.nih.gov/contract and on FedBizOpps. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to award of a contract. NO COLLECT CALLS WILL BE ACCEPTED. NO FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED. See Government-wide Numbered Note 26.
- Record
- SN01017880-W 20060401/060330211940 (fbodaily.com)
- Source
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