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| Sponsors and Collaborators: |
University of Maryland Cubist Pharmaceuticals |
| Information provided by: | University of Maryland |
| ClinicalTrials.gov Identifier: | NCT00261807 |
Purpose
Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows:
Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin.
Objective:
To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections.
Type of Study:
Open label, single center study.
| Condition | Intervention |
|
Fasciitis, Necrotizing Severe Necrotizing Skin and Soft Tissue Infections Fournier's Gangrene |
Drug: Daptomycin 6mg/kg/day |
| MedlinePlus related topics: | Antibiotics |
| ChemIDplus related topics: | Daptomycin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study |
| Official Title: | Open Label, Single Center Study to Evaluate Higher Doses of Daptomycin in the Treatment of Patients With Severe Necrotizing Skin and Soft Tissue Infections. |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria
Inclusion criteria :
A) At least three of the following clinical signs and symptoms of local infection should be present:
B) At least 1 of the two systemic conditions should be present:
Positive gram stain or wound culture obtained within 3 calendar days prior to the first dose of Daptomycin.
Exclusion criteria:
Criteria for withdrawal from the study:
Contacts and Locations| United States, Maryland | |||||
| R Adams Cowley Shock Trauma Center, U. of Maryland Medical Center | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| University of Maryland |
| Cubist Pharmaceuticals |
| Principal Investigator: | Manjari G Joshi, MD | University of Maryland, School of Medicine - Shock Trauma |
More Information
| References 1. Wang K, Shin C. Necrotizing fasciitis of the extremities. J Trauma 1992; 32:19-182. 2. Swartz MN. Cellulitis and subcutaneous tissue infections. In Mandell AL, Dolin R, Bennett JE (eds). Principles and Practice of Infectious Diseases. New York, Churchill Livingstone, 1995, p 909-929. 3. Stone HH, Martin JD. Synergistic necrotizing cellulitis. Ann. Surg. 1972; 175: 702-710. 4. Stevens DL, Tanner MH, Winship J, et al. Severe group A streptococcal infections associated with a toxic shock-like syndrome and a scarlet fever toxin. N Engl J Med 1989; 1: 321. 5. Elliott DC, Kufera JA, Myers RAM. Necrotizing soft tissue infections; risk factors for mortality and strategies for management. Ann. Surg 1966; 224: 672-683. 6. Asfar SK. Necrotizing fasciitis. Br. J. Surg. 1991; 7-8, 828-840. 7. Rotstein OD, Pruett TL, Simmons RL. Mechanisms of microbial synergy in polymicrobial surgical infections. Rev Infect Dis. 1985; 7: 151-170. 8. Naimi, TS, LeDell RH, Como-Sabelth K, et al. Comparison of community-and health care associated MRSA infection. JAMA 2003; 290: 2976. 9. Herold, BC, Immerglick LC, Maranana MC, et al. Community-acquired methicillin-resistant S. aureus in children with no identified predisposing risk. JAMA 1998; 279: 593. 10. Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin skin-structure infection.. Clin. Infect. Dis. 2004 June 15: 38 (12): 1673-81, Epub 2004 May 11. Ellie J.C.Goldstein, Diane M.Citron, C.Vreni Merriam, et al. In Vitro Activities of daptomycin, Vancomycin, Quinupristin-Dalfopristin, Linezolid, and Five Other Antimicrobials against 307 Gram-Positive Anaerobic and 31 Corynebacterium Clinical Isolates. Antimicrobial agents and chemoterapy,2003 June: 47(1) 337-341 12. Barry H.Dvorchik, PhD, FCP, and David Damphousse,MS. Pharmacokinetics of daptomycin in Moderately Obese, Morbidly obese, and Matched Nonobese Subjects.J Clin Pharmacol 2005; 45:48-56 13. Package insert for CUBICIN (daptomycin for injection) |
| Study ID Numbers: | H-26386 |
| First Received: | December 1, 2005 |
| Last Updated: | May 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00261807 |
| Health Authority: | United States: Food and Drug Administration |
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