Staphylococcus Aureus BacteremiaNCT01971762
Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology
An observational study of Staphylococcus Aureus Bacteremia, run by Fundación Pública Andaluza Progreso y Salud at 16 sites in Spain.
Trial summary
Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- What is being tested?
- Follow recommendations based on scientific evidence to S. aureus bacteremia management and Not to follow recommendations based on scientific evidence to S. aureus bacteremia management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 16 sitesSpain
- Study dates
- Apr 2011to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed bacteremia by S. aureus attended in participating centers will be included
Who may be able to join
- Patients over 14
- Clinical significant bacteremia by S. aureus
- Patient hospitalized
Who cannot join
- Non clinical significant bacteremia
- Ambulatory patient
- End-of-life patients
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Hospital de Torrecárdenas
Almería
Hospital de barcelona - SCIAS
Barcelona
Hospital de Cruces
Bilbao
Hospital Puerta del Mar
Cadiz
Hospital Reina Sofía
Córdoba
Hospital Virgen de las Nieves
Granada
Hospital Juan Ramón Jiménez
Huelva
Hospital de San Pedro
Logroño
Hospital Carlos Haya
Málaga
Hospital Virgen de la Victoria
Málaga
Hospital Costa del Sol
Marbella, Málaga
Hospital de la Arrixaca
Murcia
Hospital de Puerto Real
Puerto Real, Cádiz
Hospital de Valdecillas
Santander
Hospital Universitario Virgen de la Macarena
Seville
Hospital Virgen de Valme
Seville
About this study
Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology.
- Conditions
- Staphylococcus Aureus Bacteremia
- Being tested
- Follow recommendations based on scientific evidence to S. aureus bacteremia management, Not to follow recommendations based on scientific evidence to S. aureus bacteremia management
- Keywords
- multiresistant bacteremia, bacteremia management, blood culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow recommendations based on scientific evidence to S. aureus bacteremia managementBehavioural
Not to follow recommendations based on scientific evidence to S. aureus bacteremia managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed bacteremia by S. aureus | Not described Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesús Rodríguez-Baño, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971762
- Sponsor's protocol ID
- FPS-STA-2011-01
- Status last verified
- Nov 2013
- First submitted
- 18 Oct 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23929889
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology
- ClinicalTrials.gov ID
- NCT01971762
- Acronym / sponsor ID
- FPS-STA-2011-01
- Conditions
- Staphylococcus Aureus Bacteremia
- Keywords
- multiresistant bacteremia, bacteremia management, blood culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed bacteremia by S. aureus attended in participating centers will be included
Key inclusion criteria (3 listed)
- Patients over 14
- Clinical significant bacteremia by S. aureus
- Patient hospitalized
Key exclusion criteria (3 listed)
- Non clinical significant bacteremia
- Ambulatory patient
- End-of-life patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow recommendations based on scientific evidence to S. aureus bacteremia management | Behavioural | Patients diagnosed bacteremia by S. aureus |
| Not to follow recommendations based on scientific evidence to S. aureus bacteremia management | Behavioural | Patients diagnosed bacteremia by S. aureus |
Primary outcome
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 secondary outcomes
Follow-up blood cultures performance of control blood culture 48-96h.
Time frame: 6 months
Early source control
Time frame: 6 months
Echocardiography in patients with clinical indications
Time frame: 6 months
Early use of IV cloxacillin for meticillin susceptible Staphylococcus aureus as definitive therapy
Time frame: 6 months
Adjustment of vancomycin dose according to trough levels.
Time frame: 6 months
Treatment duration according to the complexity of infection.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Results publication: PubMed 23929889Lopez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Rodríguez-Baño principal investigator
Hospital Universitario Virgen Macarena
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Bacteremia, run by Fundación Pública Andaluza Progreso y Salud at 16 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.