Non complicated Catheter related S. aureus meticillin sensible bacteremia
Conditions
Interventions
Product Name: LEVOFLOXACINO
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LEVOFLOXACIN
CAS Number: 100986-85-4
Product Name: CLOXACILIN
Pharmaceutical Form: Powder and solvent for solution
Sponsors
FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients ? 18 years with a minimum weight of 40 kg. ? Microbiological isolation of S. aureus susceptible to methicillin. ? To start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations. ? Prescription of treatment must be prior, independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice. 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 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: ? Polymicrobial bacteremia. ? Neutropenic patients. ? Patients addicted to intravenous drugs. ? Patients with malignancies with expected survival less than 6 months. ? Severe allergy to beta-lactams. ? Creatinine clearance <20ml/min. ? Need for hemodialysis, peritoneal dialysis or plasmapheresis. ? Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis. ? Predictors of complicated bacteremia: Positive blood culture for 48-96 hours of starting treatment antistaphylococcal Clinical instability Signs of sepsis or persistent fever on day 4 of treatment Existence of joint prostheses or valvular or vascular, vascular catheter not removed within three days Underlying heart disease or endocarditis. ? Patients who present at diagnosis concomitant infection by another organism. ? Not have signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the eficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin susceptible, selected based on a set of pre-established criteria equals the pattern of the conventional intravenous;Secondary Objective: Reduce hospital stay associated with the treatment of uncomplicated bacteremia S. aureus. Increasing efficiency in the management of patients with bacteremia by S. aureus MS, reducing the number of echocardiographic evaluation.;Primary end point(s): Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin susceptible below 2%.;Timepoint(s) of evaluation of this end point: 14 days of treatment 6 months after extraction of hemoculture | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mortality rate evaluated at 7, 14 and 30 days Recovery rate: Evaluated at At the end of treatment (14 days) At the end of follow-up period (6 month);Timepoint(s) of evaluation of this end point: Mortality rate evaluated at 7, 14 and 30 days Recovery rate: Evaluated at At the end of treatment (14 days) At the end of follow-up period (6 month) | — |
Countries
Spain
Contacts
Public ContactMaria del Mar Benjumea Vargas
FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
Outcome results
None listed