Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
Primary Purpose
Staphylococcus Aureus Bacteremia
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
infectious disease specialist consultation
Sponsored by
About this trial
This is an interventional health services research trial for Staphylococcus Aureus Bacteremia focused on measuring Staphylococcus aureus, Bacteremia, Outcome, Mortality, Recurrence, Infectious Diseases specialists
Eligibility 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
Sites / Locations
- National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
ID
NO ID
Arm Description
Patients receiving an early Infectious disease consultation ( within first 48 hours of a positive blood culture)
Includes those patients who do not receive an Infectious disease consultation in the first 48 hours
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
recurrence
duration of hospitalisation
financial costs of hospitalisation
Full Information
NCT ID
NCT00622882
First Posted
February 13, 2008
Last Updated
January 6, 2014
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00622882
Brief Title
Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
Official Title
Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Bacteremia
Keywords
Staphylococcus aureus, Bacteremia, Outcome, Mortality, Recurrence, Infectious Diseases specialists
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ID
Arm Type
Active Comparator
Arm Description
Patients receiving an early Infectious disease consultation ( within first 48 hours of a positive blood culture)
Arm Title
NO ID
Arm Type
No Intervention
Arm Description
Includes those patients who do not receive an Infectious disease consultation in the first 48 hours
Intervention Type
Other
Intervention Name(s)
infectious disease specialist consultation
Other Intervention Name(s)
Health Services
Intervention Description
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)
Primary Outcome Measure Information:
Title
mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
recurrence
Time Frame
2 year
Title
duration of hospitalisation
Time Frame
1 year
Title
financial costs of hospitalisation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul A Tambyah, MD
Phone
(65)67724375
Email
mdcpat@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, MD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
11974
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, Dip ABIM
Phone
(65)67724375
Email
mdcpat@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, Dip ABIM
12. IPD Sharing Statement
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Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
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