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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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ClinicalTrials.gov Identifier: NCT01971762
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( 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.

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

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed bacteremia by S. aureus attended in participating centers will be included
Criteria

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

Information from the National Library of Medicine

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


Locations
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Spain
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
Hospital de la Arrixaca
Murcia, Spain
Hospital Carlos Haya
Málaga, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital de Valdecillas
Santander, Spain
Hospital Universitario Virgen de la Macarena
Sevilla, Spain
Hospital Virgen de Valme
Sevilla, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Principal Investigator: Jesús Rodríguez-Baño Hospital Universitario Virgen Macarena

Publications of Results:
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01971762     History of Changes
Other Study ID Numbers: FPS-STA-2011-01
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: November 2013

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
multiresistant bacteremia
bacteremia management
blood culture

Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes