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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


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
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