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

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

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus Bacteremia
• Intervention / Treatment: 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
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain
    • Hospital de Torrecárdenas
  • Barcelona, Spain
    • Hospital de barcelona - SCIAS
  • Bilbao, Spain
    • Hospital De Cruces
  • Cádiz, Spain
    • Hospital Puerta del Mar
  • Córdoba, Spain
    • Hospital Reina Sofia
  • Granada, Spain
    • Hospital Virgen de las Nieves
  • Huelva, Spain
    • Hospital Juan Ramón Jimenez
  • Logroño, Spain
    • Hospital de San Pedro
  • Murcia, Spain
    • Hospital de la Arrixaca
  • Málaga, Spain
    • Hospital Carlos Haya
  • Málaga, Spain
    • Hospital Virgen de la Victoria
  • Santander, Spain
    • Hospital de Valdecillas
  • Sevilla, Spain
    • Hospital Universitario Virgen De La Macarena
  • Sevilla, Spain
    • Hospital Virgen de Valme
  • Cádiz
    • Puerto Real, Cádiz, Spain
      • Hospital de Puerto Real
  • Málaga
    • Marbella, Málaga, Spain
      • Hospital Costa del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed bacteremia by S. aureus attended in participating centers will be included

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud
• Investigators: Principal Investigator: Jesús Rodríguez-Baño, Hospital Universitario Virgen Macarena

Publications and helpful links

General Publications

• Lopez-Cortes LE, Del Toro MD, Galvez-Acebal J, Bereciartua-Bastarrica E, Farinas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martinez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodriguez-Bano J; REIPI/SAB group. Impact of an evidence-based bundle intervention in the quality-of-care management and outcome of Staphylococcus aureus bacteremia. Clin Infect Dis. 2013 Nov;57(9):1225-33. doi: 10.1093/cid/cit499. Epub 2013 Aug 8.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: blood culture; multiresistant bacteremia; bacteremia management
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Sepsis; Bacteremia; Staphylococcal Infections
• Other Study ID Numbers: FPS-STA-2011-01