Multidrug-resistant Gram-negative Bacteria InfectionNCT03007290
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
A study testing Therapeutic drug monitoring in people with Multidrug-resistant Gram-negative Bacteria Infection, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidrug-resistant Gram-negative Bacteria Infection
- What is being tested?
- Therapeutic drug monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2017
- 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 over 18 years old.
- Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.
Who cannot join
- Those who received colistin therapy less than 48 hours
- Those who received colistin therapy through the bronchus
Trial locations and contacts
1 site in 1 country.
About this study
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin
- Being tested
- Therapeutic drug monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic drug monitoringOther
Therapeutic drug monitoring for colistin
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Group with therapeutic drug monitoring Receives: Other: Therapeutic drug monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI
Emergence rate of acute kidney injury
Measured: Through study completion, an average of 1 month
Secondary outcomes (2)
Death
Death rate
Measured: Through study completion, an average of 1 month
Negative conversion rate
Culture-negative conversion rate Treatment success Treatment success
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug-resistant Gram-negative Bacteria InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eu Suk Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007290
- Sponsor's protocol ID
- Colistin_TDM
- Status last verified
- Apr 2018
- First submitted
- 28 Dec 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
- ClinicalTrials.gov ID
- NCT03007290
- Acronym / sponsor ID
- Colistin_TDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jan 2017 (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.
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Therapeutic drug monitoringGroup with therapeutic drug monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years old.
- Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.
Key exclusion criteria (2 listed)
- Those who received colistin therapy less than 48 hours
- Those who received colistin therapy through the bronchus
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 |
|---|---|---|
| Therapeutic drug monitoringTherapeutic drug monitoring for colistin | Other | Treatment group |
Primary outcome
AKI
Time frame: Through study completion, an average of 1 month
Emergence rate of acute kidney injury
2 secondary outcomes
Death
Time frame: Through study completion, an average of 1 month
Negative conversion rate
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic drug monitoring in people with Multidrug-resistant Gram-negative Bacteria Infection, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Apr 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI (time frame: Through study completion, an average of 1 month). 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 18 Apr 2018.