SOURCES SOUGHT
A -- Clinical Trials Program for the Prevention and Treatment of Infections after Cardiac Surgery: Clinical Microbiology Laboratory
- Notice Date
- 12/24/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-05-03
- Response Due
- 1/9/2004
- Archive Date
- 1/24/2004
- Point of Contact
- Craig Miron, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
cm49x@nih.gov
- Description
- The National Heart, Lung and Blood Institute (NHLBI) and the National Institute for Allergy and Infectious Diseases (NIAID) intend to establish a Clinical Trials Program for the Prevention and Treatment of Infections after Cardiac Surgery, conducting two parallel trials that will focus on prevention and treatment of Staphylococcus aureus (S. aureus) infections in cardiac surgery patients. There are a number of new antimicrobial agents with activity against antimicrobial-resistant Gram positive bacteria on the market (Linezolid, Quinupristin/Dalfopristin, etc.). Other investigational drugs such as Lysostaphin show promise as adjunctive therapies or preventive agents. Use of newer agents may allow earlier discharge of patients or prevention of the spread of multi-drug resistant infections in the ICU environment. The information obtained from these trials will provide a rational basis for safe and effective therapy for patients undergoing cardiac surgery. This will be important because of the increasing resistance to antibiotics. Both trials will also provide scientific insight into the role of bacterial pathogens in the long-term clinical outcome of these patients. Furthermore, the results will be evaluated for significant health care cost implications. The trials will address two key questions of therapeutic strategy in the management of cardiac surgery patients: 1) Trial of Sternal Infection Prevention (TOSIP): does a strategy targeting prevention of bacterial infection confer long-term morbidity and mortality benefits in patients undergoing cardiac surgery. TOSIP will compare three interventions: a) usual care consisting of prophylactic antibiotic; b) nasal decolonizing agent (such as Lysostaphin) in addition to usual care antibiotic; and c) anti-staphylococcal vaccine in addition to usual care antibiotic. It is anticipated that 6,189 patients will be recruited. This trial will also provide scientific insights into the role of bacterial suppression in the long-term clinical outcome and the cost and quality of life implications associated with the proposed strategies. 2) The Treatment of Major Infection Trial (TOMIT): does a novel strategy employing immunotherapy targeted to alleviate infection, confer long-term morbidity and mortality benefits beyond usual anti-bacterial therapy for those patients who have a major wound infection requiring two days or more of antibiotic treatment. TOMIT will compare two interventions: a) usual care with antibiotic; and b) antibody-based immunotherapeutic agent (such as hyperimmune globulin or humanized monoclonal antibody) in addition to antibiotic. The trial will also provide scientific insights into the role of immunotherapy in the long-term clinical outcome of patients with postoperative sternal wound infections requiring systemic antibiotics and the cost and quality of life implications associated with the proposed strategies. It is anticipated that 1,244 patients will be recruited. The program will be composed of a Data Coordinating Center (DCC), a Clinical Coordinating Center (CCC) with over 100 participating clinical sites and a Core Microbiology Laboratory (CML). The NHLBI intends to release separate Requests for Proposals (RFP=s) for the DCC, CCC & CML. The CML will have primary responsibility to coordinate the collection of Staphylococcal isolates and clinical specimens from clinical sites, to develop standard operating procedures for handling, verification, characterization and distribution of specimens to internal and external investigators. The DCC will coordinate all aspects of the research and manage and analyze the patient and research data. The CCC will select, manage and coordinate the efforts of the clinical sites, including reimbursement for their protocol stipulated activities, and assure best clinical practices. The DCC, CCC & CML and a representative of the NHLBI will form a Steering Committee that serves as the governing body of the program. The CML will be responsible for developing and administering a research plan of microbiology scientific studies to be conducted in conjunction with the TOSIP and TOMIT trials (and in accordance with the established protocols) utilizing study specimens, isolates and clinical data collected in association with the clinical protocols. The primary emphasis of these studies will be on the etiology and pathogenesis of Staphylococcal infections, immunology and host response, and bacterial factors impacting upon clinical outcome. The CML will work in close collaboration with the CCC, DCC and NIH Project Officers to develop the necessary documents and procedures for sample collection, to train the clinical sites in sample collection, and to assure patient safety and confidentiality. The CML will include personnel trained in clinical microbiology methods and with scientific expertise in microbiology, immunology, and therapeutics. This announcement is a market survey to assess the availability and technical capability of small businesses as defined the NAICS code 541710 for research and development in the physical, engineering and life sciences. The appropriate size standard is 500 employees. Small business firms having demonstrated experience in meeting the requirements described above are invited to submit capability statements in original and two copies. Capability statements must provide evidence of 1) documented training, expertise, and experience in the planning and directing of research projects in the areas of bacterial pathogenesis and virulence, host response to infection, preventive and therapeutic approaches to Staphylococcal diseases, 2) clinical laboratory experience and training in the evaluations of tissue, blood, and nasal swab specimens, 3) leadership abilities and expertise in clinical microbiological methods, processing of clinical specimens and microbiologic analysis procedures including genetic characterization and antimicrobial resistance, and 4) the organization?s status as a small business under NAICS 541710. Capability statements in response to this sources sought synopsis that do not provide sufficient information for evaluation will not be considered. This is not a request for proposals and responses should not include budgetary information. The RFP release date is anticipated on or about March 31, 2004. The Government intends to award one contract for a period of 5 years, on or about April 30, 2005. Firms responding to this market survey must provide pertinent information to the requirements described above by January 9, 2004.
- Record
- SN00495537-W 20031226/031224211714 (fbodaily.com)
- Source
-
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