The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
daptomycin i.v. 4 mg/kg q24h for 7-14 days
Investigator's assessment of clinical response based on improvement of signs and symptoms
Time frame: End of Therapy
Incidence of adverse events
Time frame: first dose to end of therapy
eradication of pathogens isolated at admission
Time frame: End of Therapy
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
Time frame: End of Therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.