Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Bacteremia Clinical Trial

Official title:

Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00622882
• Other study ID #: DSRB-B/06/274
• Secondary ID: DSRB-B/06/274
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2008
• Last updated: January 6, 2014
• Start date: October 2007
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: Paul A Tambyah, MD
• Phone: (65)67724375
• Email: mdcpat[@]nus.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bacteremia
• Communicable Diseases
• Infection
• Staphylococcus Aureus Bacteremia

Intervention

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)

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		1 year	No
Secondary	recurrence		2 year	No
Secondary	duration of hospitalisation		1 year	No
Secondary	financial costs of hospitalisation		1 year	No