Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National University Hospital, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00622882
First received: February 13, 2008
Last updated: May 8, 2008
Last verified: May 2008
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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: | August 2008 |
| Estimated Primary Completion Date: | August 2008 (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
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: | Paul Tambyah/Associate Professor, National University Hospital |
| 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: | May 8, 2008 |
| 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 Staphylococcal Infections Bacterial Infections |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Gram-Positive Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013