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

Staphylococcus Aureus Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971762
• Other study ID #: FPS-STA-2011-01
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: December 4, 2014
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2013
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcus Aureus Bacteremia

Intervention

Behavioral:
• Follow recommendations based on scientific evidence to S. aureus bacteremia management

• Not to follow recommendations based on scientific evidence to S. aureus bacteremia management

Locations

Country	Name	City	State
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	Hospital Carlos Haya	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital de la Arrixaca	Murcia
Spain	Hospital de Puerto Real	Puerto Real	Cádiz
Spain	Hospital de Valdecillas	Santander
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Virgen de Valme	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

References & Publications (1)

López-Cortés LE, Del Toro MD, Gálvez-Acebal J, Bereciartua-Bastarrica E, Fariñas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martínez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodríguez-Baño J; REIPI/SAB group. Impact of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall target is to assess if the implementation of an active intervention program improves clinical management of the disease, according to existing recommendations.	Identify evidence-based quality-of-care indicators (QCIs) for the management of Staphylococcus aureus bacteremia (SAB).; See secondary objective for the definitions of QCIs	6 months	No
Secondary	Follow-up blood cultures performance of control blood culture 48-96h.	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.	6 months	No
Secondary	Early source control	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	6 months	No
Secondary	Echocardiography in patients with clinical indications	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	6 months	No
Secondary	Early use of IV cloxacillin for meticillin susceptible Staphylococcus aureus as definitive therapy	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.	6 months	No
Secondary	Adjustment of vancomycin dose according to trough levels.	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.	6 months	No
Secondary	Treatment duration according to the complexity of infection.	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	6 Months	No