Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia - Full Text View

Sponsored by:	National University Hospital, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00622882

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:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia

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:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ID: Active Comparator 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)
NO ID: No Intervention 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

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:	National University Hospital ( Paul Tambyah/Associate Professor )
Study ID Numbers:	DSRB-B/06/274, DSRB-B/06/274
Study First Received:	February 13, 2008
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00622882 History of Changes
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:

Staphylococcus aureus
Bacteremia
Outcome

Mortality
Recurrence
Infectious Diseases specialists

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Sepsis
Bacteremia
Recurrence
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Staphylococcal Infections
Communicable Diseases
Gram-Positive Bacterial Infections

Sepsis
Pathologic Processes
Bacteremia
Infection
Inflammation

ClinicalTrials.gov processed this record on September 03, 2009