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Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia

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ClinicalTrials.gov Identifier: NCT00622882
Recruitment Status : Unknown
Verified January 2014 by Medicine, National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : February 25, 2008
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore

Brief Summary:
The primary objective is to determine if early infectious disease (ID) consultation (defined as within 48 hours of a positive blood culture) will reduce mortality rates from Staphylococcus aureus bacteremia (SAB). This study will also determine if such consultations could reduce the duration of hospitalisation, recurrence and financial costs in patients with this infection.

Condition or disease Intervention/treatment
Staphylococcus Aureus Bacteremia Other: infectious disease specialist consultation

Detailed Description:

Bacteremia is a serious manifestation of Staphylococcus aureus infection with an attributable mortality as high as 25% in MRSA bacteremia. More than a third of patients end up with complications such as endocarditis, osteomyelitis or pneumonia.

Overall the outcome of patients with respect to mortality or recurrence is better in patients who have an eradicable focus and have received an appropriate antibiotic dose and duration. Also complicated bacteremia is more common in patients with

  • persistent bacteremia or fever
  • prosthetic device
  • new murmur
  • skin findings of a systemic infection

Based on this evidence, an ID consultation could improve the outcomes of patients with SAB by

  • Advising adequate antibiotic dosage and duration
  • Sourcing out and counselling eradication of any focus of infection

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia
Study Start Date : October 2007
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ID
Patients receiving an early Infectious disease consultation ( within first 48 hours of a positive blood culture)
Other: infectious disease specialist consultation
Randomised trial to determine the utility of an early Infectious disease Consultation in Staphylococcus aureus bacteremic patients ( in the first 48 hours of a positive blood culture)
Other Name: Health Services
No Intervention: NO ID
Includes those patients who do not receive an Infectious disease consultation in the first 48 hours

Primary Outcome Measures :
  1. mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. recurrence [ Time Frame: 2 year ]
  2. duration of hospitalisation [ Time Frame: 1 year ]
  3. financial costs of hospitalisation [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All inpatients at the National University Hospital with Staphylococcus aureus (both methicillin sensitive and methicillin resistant) bacteremia isolated within the defined time period

Exclusion Criteria:

  • Patients who died or were discharged before the notification from the laboratory
  • Neonates
  • Polymicrobial bacteremia

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): NCT00622882

Contact: Paul A Tambyah, MD (65)67724375 mdcpat@nus.edu.sg

National University Hospital Recruiting
Singapore, Singapore, 11974
Contact: Paul A Tambyah, Dip ABIM    (65)67724375    mdcpat@nus.edu.sg   
Principal Investigator: Paul A Tambyah, Dip ABIM         
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Paul A Tambyah, MD National University, Singapore

Responsible Party: Medicine, Professor Paul Ananth Tambyah, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00622882     History of Changes
Other Study ID Numbers: DSRB-B/06/274
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Medicine, National University Hospital, Singapore:
Staphylococcus aureus
Infectious Diseases specialists

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes