Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infect… (NCT00463801) | Clinical Trial Compass
TerminatedPhase 4
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Stopped: Because of inadequate accrual.
Italy52 participantsStarted 2007-01
Plain-language summary
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
* Infection to be due to Gram-positive bacteria
* Hospitalized subjects
* Written informed consent
* Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.
Exclusion criteria:
* Complicated skin and skin-structure infections of the following categories:
* Infected burns
* Severely impaired arterial blood supply
* Decubitus ulcers
* Infected diabetic foot ulcers associated with osteomyelitis
* Infected human or animal bites
* Perirectal abscess
* Necrotising fasciitis or gangrene
* Infections expected to require more than 14 days of intravenous antimicrobial therapy
* Skin and/or skin structure infection that can be treated by surgery alone
* Infections associated with a permanent prosthetic device that will not be removed within 2 days of study enrollment
* Uncomplicated skin or soft tissue infection
* Documented bacteremia at baseline
* Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
* Hospitalization for conditions related to rhabdomyolysis
* Human immunodeficiency virus (HIV) with cluster of differentiation (CD) \< 200 or \< 14%
* Immune …
What they're measuring
1
Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start