Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01971762|
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment|
|Staphylococcus Aureus Bacteremia||Behavioral: Follow recommendations based on scientific evidence to S. aureus bacteremia management Behavioral: Not to follow recommendations based on scientific evidence to S. aureus bacteremia management|
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||January 2012|
|Patients diagnosed bacteremia by S. aureus||
Behavioral: Follow recommendations based on scientific evidence to S. aureus bacteremia management
Behavioral: Not to follow recommendations based on scientific evidence to S. aureus bacteremia management
- 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 ]
Identify evidence-based quality-of-care indicators (QCIs) for the management of Staphylococcus aureus bacteremia (SAB).
See secondary objective for the definitions of QCIs
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971762
|Hospital de Puerto Real|
|Puerto Real, Cádiz, Spain|
|Hospital Costa del Sol|
|Marbella, Málaga, Spain|
|Hospital de Torrecárdenas|
|Hospital de barcelona - SCIAS|
|Hospital de Cruces|
|Hospital Puerta del Mar|
|Hospital Reina Sofía|
|Hospital Virgen de las Nieves|
|Hospital Juan Ramón Jiménez|
|Hospital de San Pedro|
|Hospital de la Arrixaca|
|Hospital Carlos Haya|
|Hospital Virgen de la Victoria|
|Hospital de Valdecillas|
|Hospital Universitario Virgen de la Macarena|
|Hospital Virgen de Valme|
|Principal Investigator:||Jesús Rodríguez-Baño||Hospital Universitario Virgen Macarena|