NCT01971762

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

December 5, 2014

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

October 18, 2013

Last Update Submit

December 4, 2014

Conditions

Staphylococcus Aureus Bacteremia

Keywords

multiresistant bacteremiabacteremia managementblood culture

Outcome Measures

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.

    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 Outcomes (6)

  • Follow-up blood cultures performance of control blood culture 48-96h.

    6 months

  • Early source control

    6 months

  • Echocardiography in patients with clinical indications

    6 months

  • Early use of IV cloxacillin for meticillin susceptible Staphylococcus aureus as definitive therapy

    6 months

  • Adjustment of vancomycin dose according to trough levels.

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Patients diagnosed bacteremia by S. aureus

Behavioral: Follow recommendations based on scientific evidence to S. aureus bacteremia managementBehavioral: Not to follow recommendations based on scientific evidence to S. aureus bacteremia management

Interventions

Follow recommendations based on scientific evidence to S. aureus bacteremia managementBEHAVIORAL
Patients diagnosed bacteremia by S. aureus
Not to follow recommendations based on scientific evidence to S. aureus bacteremia managementBEHAVIORAL
Patients diagnosed bacteremia by S. aureus

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients over 14
  • Clinical significant bacteremia by S. aureus
  • Patient hospitalized

You may not qualify if:

  • Non clinical significant bacteremia
  • Ambulatory patient
  • End-of-life patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital de Puerto Real

Puerto Real, Cádiz, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, Spain

Location

Hospital de Torrecárdenas

Almería, Spain

Location

Hospital de barcelona - SCIAS

Barcelona, Spain

Location

Hospital de Cruces

Bilbao, Spain

Location

Hospital Puerta del Mar

Cadiz, Spain

Location

Hospital Reina Sofía

Córdoba, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, Spain

Location

Hospital de San Pedro

Logroño, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

Hospital de la Arrixaca

Murcia, Spain

Location

Hospital de Valdecillas

Santander, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Spain

Location

Hospital Virgen de Valme

Seville, Spain

Location

Related Publications (1)

  • 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.

    PMID: 23929889RESULT

Study Officials

  • Jesús Rodríguez-Baño

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 29, 2013

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

December 5, 2014

Record last verified: 2013-11

Locations

ES(16)