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

Completed

• Conditions: Staphylococcus Aureus Bacteremia

• Registration Number: NCT01971762
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Status Verified: 2013-11
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients over 14
• Clinical significant bacteremia by S. aureus
• Patient hospitalized

Exclusion Criteria

• Non clinical significant bacteremia
• Ambulatory patient
• End-of-life patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The overall target is to assess if the implementation of an active intervention program improves clinical management of the disease, according to existing recommendations.	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

Secondary Outcome Measures

Name	Time	Method
Follow-up blood cultures performance of control blood culture 48-96h.	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 use of IV cloxacillin for meticillin susceptible Staphylococcus aureus as definitive therapy	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.
Early source control	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
Adjustment of vancomycin dose according to trough levels.	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.
Echocardiography in patients with clinical indications	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
Treatment duration according to the complexity of infection.	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

Trial Locations

Locations (16)

Hospital de Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital de Torrecárdenas; 🇪🇸 Almería, Spain

Hospital de barcelona - SCIAS; 🇪🇸 Barcelona, Spain

Hospital de Cruces; 🇪🇸 Bilbao, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital de San Pedro; 🇪🇸 Logroño, Spain

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