Status:
COMPLETED
Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Fasciitis, Necrotizing
Severe Necrotizing Skin and Soft Tissue Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Staphylococ...
Detailed Description
At the shock trauma center, the management of patients with NSTI is conducted in the following fashion: All new patients with NSTI are admitted to the trauma center through the 12-bed shock trauma adm...
Eligibility Criteria
Inclusion
- Inclusion/Exclusion Criteria
- Inclusion criteria :
- Read and sign the consent form. If patient is unable to sign, the consent will be obtained from a legally authorized representative.
- Male or female \> 18 years of age
- If female of child bearing potential, negative pregnancy test
- Surgical diagnosis of severe necrotizing fasciitis, severe necrotizing skin and soft tissue infections (e.g. Fournier's gangrene)
- A) At least three of the following clinical signs and symptoms of local infection should be present:
- pain out of proportion to clinical findings
- tenderness to palpation
- swelling
- erythema
- induration
- pus formation
- B) At least 1 of the two systemic conditions should be present:
- Elevated temps.\[100.4\] or reduced temps. \[\<96\]
- WBC counts \> 12.00/cu.mm
- Positive gram stain or wound culture obtained within 3 calendar days prior to the first dose of Daptomycin.
- positive gram stain would include gram positive cocci or gram positive rods
- positive wound culture would include growth of staphylococci and/or streptococci and/or enterococcus and/or clostridia (Clostridium perfringens ).
- If the patient is on HMG-CoA reductase inhibitors then these agents will be discontinued at the study initiation and resumed after discontinuation of daptomycin.
- Exclusion criteria:
- If female, pregnant, or lactating and breast-feeding
- Previous antibiotic therapy exceeding 72 hours duration, unless patient is worsening clinically or has gram positive pathogens cultured from wound that are resistant to current antibiotic therapy.
- Sites of infection other than skin i.e., osteomyelitis, meningitis, bacteremia, etc.
- Known to be allergic or intolerant to study medications
- Expected to die in \< 5 days
- Significant renal impairment - creatinine clearance \< 30m/min
- A primary diagnosis of uncomplicated skin infections, such as cellulitis, minor post-op. wound infection, small decubitus ulcer etc.
- Patients with baseline CPKs equal to or greater than 10 times upper limit of normal without myopathy and CPK elevation of greater than or equal to 5 times upper limit of normal with symptoms of myopathy
- Documentation of myoglobinuria at onset of the study. The study will be conducted over a one-year period. We are anticipating enrollment of 25 patients on the study.
- Criteria for withdrawal from the study:
- If the patient complains of myalgias and has high CPK values as specified below.
- If the patient develops myoglobinuria, CPKs equal to or 10 times upper limit of normal without myopathy and CPK elevation of greater than 5 times upper limit of normal with symptoms of myopathy.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00261807
Start Date
June 1 2005
End Date
May 1 2008
Last Update
January 27 2022
Active Locations (1)
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1
R Adams Cowley Shock Trauma Center, U. of Maryland Medical Center
Baltimore, Maryland, United States, 21201