- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971762
Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Almería, Spain
- Hospital de Torrecárdenas
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Barcelona, Spain
- Hospital de barcelona - SCIAS
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Bilbao, Spain
- Hospital De Cruces
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Cádiz, Spain
- Hospital Puerta del Mar
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Córdoba, Spain
- Hospital Reina Sofia
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Granada, Spain
- Hospital Virgen de las Nieves
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Huelva, Spain
- Hospital Juan Ramón Jimenez
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Logroño, Spain
- Hospital de San Pedro
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Murcia, Spain
- Hospital de la Arrixaca
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Málaga, Spain
- Hospital Carlos Haya
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Málaga, Spain
- Hospital Virgen de la Victoria
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Santander, Spain
- Hospital de Valdecillas
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Sevilla, Spain
- Hospital Universitario Virgen De La Macarena
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Sevilla, Spain
- Hospital Virgen de Valme
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Cádiz
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Puerto Real, Cádiz, Spain
- Hospital de Puerto Real
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Málaga
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Marbella, Málaga, Spain
- Hospital Costa del Sol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients diagnosed bacteremia by S. aureus
|
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.
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 |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 months
|
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 |
6 months
|
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 |
6 months
|
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. |
6 months
|
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 months
|
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 |
6 Months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jesús Rodríguez-Baño, Hospital Universitario Virgen Macarena
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPS-STA-2011-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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