BacteremiaNCT03765749
Empirical Antibiotic and Outcome in Community-onset Bacteremia
An observational study of Bacteremia, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- 22 Nov 2018to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Patient with community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae. Age > 18 years
Who may be able to join
- Patient with Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae. Age > 18 years
Who cannot join
- Pregnancy
- Polymicrobial infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empirical Antibiotic and Outcome in Community-onset Bacteremia Caused by Third Generation Cephalosporin Resistant Enterobacteriaceae
Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae
Read the detailed description
Prospective cohort study is conducted for monitoring outcomes and risk factors among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.
Primary endpoint is mortality rate among those who received initially inappropriate antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial susceptibility test reported among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.
- Conditions
- Bacteremia
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community onset 3rd generation cephalosporin resistant entero | Patient with Community onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received inappropriate Antibiotic | |
| Nosocomial onset 3rd generation cephalosporin resistant ente | Patient with Nosocomial onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received appropriate Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae
Measured: January 2018 - march 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start22 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasin Vasikasin, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765749
- Sponsor's protocol ID
- PMK-032
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2018
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nasomsong W, Changpradub D, Vasikasin V. Impact of Inappropriate Empirical Antibiotic on Outcomes in Community-acquired Third Generation Cephalosporin Resistant Enterobacterales Bacteremia. Infect Chemother. 2022 Dec;54(4):722-732. doi: 10.3947/ic.2022.0096.
PubMed 36596682
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Antibiotic and Outcome in Community-onset Bacteremia Caused by Third Generation Cephalosporin Resistant Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT03765749
- Acronym / sponsor ID
- PMK-032
- Conditions
- Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Dec 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.
Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae
Detailed description
Prospective cohort study is conducted for monitoring outcomes and risk factors among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.
Primary endpoint is mortality rate among those who received initially inappropriate antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial susceptibility test reported among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community onset 3rd generation cephalosporin resistant entero | – | –Patient with Community onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received inappropriate Antibiotic |
| Nosocomial onset 3rd generation cephalosporin resistant ente | – | –Patient with Nosocomial onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received appropriate Antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae. Age > 18 years
Key inclusion criteria (1 listed)
- Patient with Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae. Age > 18 years
Key exclusion criteria (2 listed)
- Pregnancy
- Polymicrobial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae
Time frame: January 2018 - march 2019
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 19 Apr 2022.
- Derived from this study: PubMed 36596682Nasomsong W, Changpradub D, Vasikasin V. Impact of Inappropriate Empirical Antibiotic on Outcomes in Community-acquired Third Generation Cephalosporin Resistant Enterobacterales Bacteremia. Infect Chemother. 2022 Dec;54(4):722-732. doi: 10.3947/ic.2022.0096.
- 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?
An observational study of Bacteremia, run by Phramongkutklao College of Medicine and Hospital 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 1 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 19 Apr 2022. 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?
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?
Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae (time frame: January 2018 - march 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765749, which also lists 1 linked publication.
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 19 Apr 2022.