Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00622882
First received: February 13, 2008
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention
Staphylococcus Aureus Bacteremia
Other: infectious disease specialist consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrence [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • duration of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • financial costs of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622882

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

Locations
Singapore
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
Investigators
Principal Investigator: Paul A Tambyah, MD National University, Singapore
  More Information

No publications provided

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, DSRB-B/06/274
Study First Received: February 13, 2008
Last Updated: January 6, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Staphylococcus aureus
Bacteremia
Outcome
Mortality
Recurrence
Infectious Diseases specialists

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

ClinicalTrials.gov processed this record on August 21, 2014