SOURCES SOUGHT
A -- Clinical Trials Program for the Prevention and Treatment of Infections after Cardiac Surgery: Data Coordinating Center
- 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-05-02
- 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 type of 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 and 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 with 30 days of intervention. 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 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 CML will be responsible for coordinating the collection of Staphylococcal isolates and clinical specimens from clinical sites, developing standard operating procedures for handling, verification, characterization and distribution of specimens to internal and external investigators. 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 DCC will provide leadership in the statistical issues including the design of study protocols and analysis of study data. The DCC will be responsible for the design or selection and management of data collection tools and ensuring quality control. The DCC will identify a Drug Distribution Center and develop a plan for coordination and distribution of drugs to the clinical sites. The DCC will coordinate the random assignment of patients to two trials, be responsible for maintenance of data forms, computer systems for storage, retrieval, and for ensuring the timely collection, entry and editing of the data. The DCC will also be responsible for coordinating communications among the various components of the study, and scheduling meetings and conference calls of the study committees as needed. The DCC will also organize the Data Safety Monitoring Board (DSMB) and Protocol Review Committee (PRC) meetings and prepare statistical reports and minutes of these meetings. The DCC in collaboration with the CCC will arrange and conduct site visits to the clinical sites. The DCC will prepare confidential reports and analyses for NHLBI review committees including PRC and DSMB. 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) availability of professional staff qualified in management of clinical trials in critically ill patients, 2) experience of the organization to manage a program of this scope, 3) facilities for performance of the requirements listed above, 4) personnel experienced in data management and biostatistics, and 5) 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
- SN00495538-W 20031226/031224211716 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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