S. Aureus spondylodiscitis MedDRA version: 9.1 Level: LLT Classification code 10062691
Conditions
Interventions
Trade Name: CUBICIN
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Daptomycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 350-
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinical, biohumoral, radiological diagnosis and positive bone biopsy for S.Aureus spondylodiscitis. Patients with clinical, biohumoral, radiological probable diagnosis and blood cultures positive for S.Aureus, Written Informed Consent. 18 years old aged. Women with negative pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concomitant infections; patients affected by rhabdomyolysis and/or raise of CPK value; patients using drugs causing myopathy or raise of CPK value; immune system diseases; pneumonia; hypersensitivity towards daptomycin; severe renal or liver failure; severe adverse event; severe clinical conditions; patiens unable to follow the study prescriptions; use of other investigational drugs in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy evaluation of S. Aureus spondylodiscitis treatment with daptomycin after 3 months from the beginning of therapy.;Secondary Objective: Number of patients reaching clinical stabilization at 4(+2) weeks of treatment. Consolidation treatment with home oral therapy. Number of patients with a persistent clinical stabilization at the edn of study.;Primary end point(s): Efficacy of treatment after 3 months from the starting of therapy. | — |
Countries
Italy
Outcome results
None listed