Phase 3
N=265
China Registration Study in Patients With Skin Infections
Skin Diseases · Infectious
Bottom Line
View on ClinicalTrials.gov: NCT00772447 ↗Enrolled (actual)
265
Serious AEs
—
Results posted
Mar 2015
Primary outcome: Primary: Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood) — 0.00; 0.01 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Daptomycin (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood) |
0.00; 0.01 | — |
| PRIMARY Change in Creatinine Clearance |
9.91; 0.99 | — |
| PRIMARY Change in Serum Total Creatine Phosphokinase (CPK) |
0.60; -2.40 | — |
| PRIMARY Change in Urine pH |
-0.19; -0.30 | — |
| PRIMARY Shift in ECG |
5.4; 7.8 | — |
| SECONDARY Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure) |
93.5; 90.1 | — |
| SECONDARY Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy) |
90.9; 91.3 | — |
| SECONDARY Microbiological Response at TOC(Test of Cure) |
94.0; 90.7 | — |
| SECONDARY Microbiological Response at EOT(End of Therapy) |
89.5; 87.5 | — |
| SECONDARY Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure) |
100; 90 | — |
| SECONDARY Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC |
90.9; 89.2 | — |
| SECONDARY Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC |
91.7; 87.5 | — |
Summary
The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.
Eligibility Criteria
Inclusion Criteria
- Provision of inform consent
- A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
- Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing
Exclusion Criteria
- Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
- Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
- Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
- Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)
Data sourced from ClinicalTrials.gov (NCT00772447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.