Clinical Trial: Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology

Brief Summary: Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology.

Detailed Summary:
Sponsor: Fundación Pública Andaluza Progreso y Salud

Current Primary Outcome: The overall target is to assess if the implementation of an active intervention program improves clinical management of the disease, according to existing recommendations. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Follow-up blood cultures performance of control blood culture 48-96h. [ Time Frame: 6 months ]

  Description:Performance of control blood cultures 48-96 h after antimicrobial therapy was started regardless of clinical evolution

  Formula:Patients with follow-up blood culture collected×100/Patients alive at 96h.

• Early source control [ Time Frame: 6 months ]

  Description: Removal of nonpermanent vascular catheter whenever the catheter was suspected or confirmed as the source of SAB, or drainage of an abscess in <72 h.

  Formula: Patients in which the amenable source was removed in<72h×100/Patients with source amenable of removal/drainage

• Echocardiography in patients with clinical indications [ Time Frame: 6 months ]

  Description: Performance of echocardiography in patients with complicated bacteremia or predisposing conditions for endocarditis.

  Formula: Patients with echocardiography×100/Patients with complicated bacteremia or predisposing condition for endocarditis,alive at 96h

• Early use of IV cloxacillin for meticillin susceptible Staphylococcus aureus as definitive therapy [ Time Frame: 6 months ]

  Description: Definitive therapy with intravenous cloxacillin (at least 2 g every 6 h or adjusted based on renal function in renal failure) in cases of methicillin-susceptible strains (allergic patients excluded). Treatment should be started within the first 24 h after methicillin sensitivity was available. For hemodialysis patients, cefazolin 2 g after each hemodialysis session was acceptable

  Formula: Definitive therapy with IV cloxacillin×100/nonallergic Patients with methicillin-susceptible isolates.

• Adjustment of vancomycin dose according to trough levels. [ Time Frame: 6 months ]

  Description: Measurement of trough levels of vancomycin in patients treated for at least 3 d with this antibiotic and adjustment of dose in order to achieve plasma trough levels between 15 and 20 mg/L in survivors

  Formula: Patients with trough level of vancomycin determined and dose adjusted×100/Patients treated with vancomycin,at 3d.

• Treatment duration according to the complexity of infection. [ Time Frame: 6 Months ]

  Description: Duration of antimicrobial therapy of at least 14 d for uncomplicated bacteremia and 28 d for complicated bacteremia. Sequential oral treatment with fluoroquinolone plus rifampin, trimethoprim-sulfamethoxazole, or linezolid was considered accepted in selected case.

  Formula:Patients with appropriate duration of therapy×100/P alive at 14 or 28d in uncomplicated or complicated bacteremia

Original Secondary Outcome: Same as current

Information By: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Dates:
Date Received: October 18, 2013
Date Started: April 2011
Date Completion:
Last Updated: December 4, 2014
Last Verified: November 2013