|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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:
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 |
| 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) |
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 | |
| Principal Investigator: | Manjari G Joshi, MD | University of Maryland, School of Medicine - Shock Trauma |
More Information
| Study ID Numbers: | H-26386 |
| Study First Received: | December 1, 2005 |
| Last Updated: | May 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00261807 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
severe skin infections |
|
Bacterial Infections Soft Tissue Infections Fasciitis, Necrotizing Fournier Gangrene Skin Diseases Gangrene Genital Diseases, Male |
Daptomycin Anti-Bacterial Agents Necrosis Musculoskeletal Diseases Skin Diseases, Bacterial Fasciitis |
|
Bacterial Infections Anti-Infective Agents Communicable Diseases Soft Tissue Infections Fasciitis, Necrotizing Fournier Gangrene Gangrene Infection Genital Diseases, Male |
Pharmacologic Actions Daptomycin Anti-Bacterial Agents Necrosis Pathologic Processes Musculoskeletal Diseases Therapeutic Uses Skin Diseases, Bacterial Fasciitis |