SepticemiaNCT03583762
Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique
A study testing Mass spectrometry and Microarray assay in people with Septicemia, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septicemia
- What is being tested?
- Mass spectrometry and Microarray assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 30 Jul 2018to 31 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018
- Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital
- Ability to provide informed consent
Who cannot join
- Suspected contaminated positive blood culture
- Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
- Terminally ill patients
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.
Read the detailed description
Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.
- Conditions
- Septicemia
- Being tested
- Mass spectrometry, Microarray assay
- Keywords
- Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass spectrometryDiagnostic test
Molecular diagnostic test for bacterial identification from bacterial colony
Microarray assayDiagnostic test
Bacterial identification by Microarray assay from positive blood culture and confirmed by Mass spectrometry technique from bacterial colony. Adjusted antibiotic therapy according to AST Re-evaluation after treatment
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention group | Experimental | 100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique Receives: Diagnostic Test: Mass spectrometry |
| Post-intervention group | Experimental | 100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique Receives: Diagnostic Test: Microarray assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures
Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)
Measured: 4 days from positive hemoculture
Secondary outcomes (4)
Mortality rate at 2 weeks
To compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment
Measured: 14 days from positive hemoculture
Length of hospital stays
To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
Measured: 30 days
Cost of antibiotic therapy
To compare the cost of antibiotics for the course of treatment during study period between 2 study period (Mass spectrometry technique and Microarray assay group)
Measured: 14 days
Percentage of De-escalation or escalation antibiotic
To compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start30 Jul 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romanee Chaiwarith, Chiang Mai University
- Investigators
- Parichart Sakulkonkij, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583762
- Sponsor's protocol ID
- MED-2561-05383
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
- ClinicalTrials.gov ID
- NCT03583762
- Acronym / sponsor ID
- MED-2561-05383
- Conditions
- Septicemia
- Keywords
- Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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.
This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.
Detailed description
Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | Experimental | Diagnostic Test: Mass spectrometry100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique |
| Post-intervention group | Experimental | Diagnostic Test: Microarray assay100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018
- Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Suspected contaminated positive blood culture
- Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
- Terminally ill patients
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 |
|---|---|---|
| Mass spectrometryMolecular diagnostic test for bacterial identification from bacterial colony | Diagnostic test | Pre-intervention group |
| Microarray assayBacterial identification by Microarray assay from positive blood culture and confirmed by Mass spectrometry technique from bacterial colony. Adjusted antibiotic therapy according to AST Re-evaluation after treatment | Diagnostic test | Post-intervention group |
Primary outcome
To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures
Time frame: 4 days from positive hemoculture
Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)
4 secondary outcomes
Mortality rate at 2 weeks
Time frame: 14 days from positive hemoculture
Length of hospital stays
Time frame: 30 days
Cost of antibiotic therapy
Time frame: 14 days
Percentage of De-escalation or escalation antibiotic
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Parichart Sakulkonkij, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mass spectrometry and Microarray assay in people with Septicemia, run by Chiang Mai University at 1 site in Thailand.
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 3 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 11 Jul 2018. 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 Thailand. 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 Parichart Sakulkonkij, MD (+66-81595-8662, papi-jung@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures (time frame: 4 days from positive hemoculture). 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 11 Jul 2018.