Staphylococcus Aureus BacteremiaNCT00622882
Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
A study testing infectious disease specialist consultation in people with Staphylococcus Aureus Bacteremia, run by National University Hospital, Singapore at 1 site in Singapore.
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). Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- What is being tested?
- infectious disease specialist consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All inpatients at the National University Hospital with Staphylococcus aureus (both methicillin sensitive and methicillin resistant) bacteremia isolated within the defined time period
Who cannot join
- Patients who died or were discharged before the notification from the laboratory
- Neonates
- Polymicrobial bacteremia
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 11974
Paul A Tambyah, Dip ABIM, (65)67724375, mdcpat@nus.edu.sg
Paul A Tambyah, Dip ABIM
About this study
Official title: Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia
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.
Read the 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
- Conditions
- Staphylococcus Aureus Bacteremia
- Being tested
- infectious disease specialist consultation
- Keywords
- Staphylococcus aureus, Bacteremia, Outcome, Mortality, Recurrence, Infectious Diseases specialists
- Medical subject headings
- Staphylococcal Infections, Bacteremia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infectious disease specialist consultationOther
Also called Health Services
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)
| Study group | Role | What they receive |
|---|---|---|
| ID | Active comparator | Patients receiving an early Infectious disease consultation ( within first 48 hours of a positive blood culture) Receives: Other: infectious disease specialist consultation |
| NO ID | No intervention | Includes those patients who do not receive an Infectious disease consultation in the first 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 1 year
Secondary outcomes (3)
recurrence
Measured: 2 year
duration of hospitalisation
Measured: 1 year
financial costs of hospitalisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Paul A Tambyah, MD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622882
- Sponsor's protocol ID
- DSRB-B/06/274
- Other IDs
- DSRB-B/06/274
- Status last verified
- Jan 2014
- First submitted
- 13 Feb 2008
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT00622882
- Acronym / sponsor ID
- DSRB-B/06/274
- Conditions
- Staphylococcus Aureus Bacteremia
- Keywords
- Staphylococcus aureus, Bacteremia, Outcome, Mortality, Recurrence, Infectious Diseases specialists
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ID | Active comparator | Other: infectious disease specialist consultationPatients receiving an early Infectious disease consultation ( within 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 |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All inpatients at the National University Hospital with Staphylococcus aureus (both methicillin sensitive and methicillin resistant) bacteremia isolated within the defined time period
Key exclusion criteria (3 listed)
- Patients who died or were discharged before the notification from the laboratory
- Neonates
- Polymicrobial bacteremia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infectious disease specialist consultationAlso: Health ServicesRandomised 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 | ID |
Primary outcome
mortality
Time frame: 1 year
3 secondary outcomes
recurrence
Time frame: 2 year
duration of hospitalisation
Time frame: 1 year
financial costs of hospitalisation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Tambyah, MD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infectious disease specialist consultation in people with Staphylococcus Aureus Bacteremia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul A Tambyah, MD ((65)67724375, mdcpat@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.