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NCT Number: NCT01971762

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.

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Key information

Conditions

Staphylococcus Aureus Bacteremia

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Puerto Real, Puerto Real, Cádiz, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 29, 2013
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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