BacteremiaNCT03925402
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
An observational study of Bacteremia and Infection, Bacterial, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bacteremia, Infection, Bacterial
- What is being tested?
- Ertapenem and Carbapenems
- Type of treatment
- Injection or infusion
- How many people
- 427 participants
- Where
- 1 siteThailand
- Study dates
- 15 May 2019to 1 Oct 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period will be included.
Who may be able to join
- Adults, either sex, ages 18 years or above
- Patients with 3GCRE bacteremia
- Patients admitted to any of the study sites
Who cannot join
- Discontinuation of antibiotic due to transition to hospice care
- Polymicrobial bacteremia
- Empirical antibiotic after 24 hours of first evidence of bacteremia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis
This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.
Read the detailed description
There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.
- Conditions
- Bacteremia, Infection, Bacterial
- Being tested
- Ertapenem, Carbapenems
- Medical subject headings
- Bacteremia, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Ertapenem injection
CarbapenemsDrug
Other carbapenems injection
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Patients who received ertapenem as an empirical antibiotic Receives: Drug: Ertapenem | |
| Other carbapenems | Patients who received carbapenems other than ertapenem as an empirical antibiotic Receives: Drug: Carbapenems |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
death from any cause within 30 days after the blood culture with bacteraemia is drawn
Measured: 30 days
Secondary outcomes (4)
In-hospital mortality
death from any cause within the duration of admission with bacteraemia
Measured: 90 days
14-day mortality
death from any cause within 14 days after the blood culture with bacteraemia is drawn
Measured: 14 days
90-day mortality
death from any cause within 90 days after the blood culture with bacteraemia is drawn
Measured: 90 days
• Length of stay
Duration of admission with bacteraemia
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start15 May 2019
- Primary completion31 Dec 2021
- Study completion1 Oct 2022
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
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925402
- Sponsor's protocol ID
- AMED2019
- Status last verified
- Mar 2023
- First submitted
- 20 Apr 2019
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vasikasin V, Panuvatvanich B, Rawson TM, Holmes AH, Nasomsong W. Towards optimizing carbapenem selection in stewardship strategies: a prospective propensity score-matched study of ertapenem versus class 2 carbapenems for empirical treatment of third-generation cephalosporin-resistant Enterobacterales bacteraemia. J Antimicrob Chemother. 2023 Jul 5;78(7):1748-1756. doi: 10.1093/jac/dkad165.
PubMed 37252945
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis
- ClinicalTrials.gov ID
- NCT03925402
- Acronym / sponsor ID
- AMED2019
- Conditions
- Bacteremia, Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Apr 2019 (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 study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.
Detailed description
There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | – | Drug: ErtapenemPatients who received ertapenem as an empirical antibiotic |
| Other carbapenems | – | Drug: CarbapenemsPatients who received carbapenems other than ertapenem as an empirical antibiotic |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period will be included.
Key inclusion criteria (3 listed)
- Adults, either sex, ages 18 years or above
- Patients with 3GCRE bacteremia
- Patients admitted to any of the study sites
Key exclusion criteria (3 listed)
- Discontinuation of antibiotic due to transition to hospice care
- Polymicrobial bacteremia
- Empirical antibiotic after 24 hours of first evidence of 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 |
|---|---|---|
| ErtapenemErtapenem injection | Drug | Ertapenem |
| CarbapenemsOther carbapenems injection | Drug | Other carbapenems |
Primary outcome
30-day mortality
Time frame: 30 days
death from any cause within 30 days after the blood culture with bacteraemia is drawn
4 secondary outcomes
In-hospital mortality
Time frame: 90 days
14-day mortality
Time frame: 14 days
90-day mortality
Time frame: 90 days
• Length of stay
Time frame: 90 days
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 29 Mar 2023.
- Derived from this study: PubMed 37252945Vasikasin V, Panuvatvanich B, Rawson TM, Holmes AH, Nasomsong W. Towards optimizing carbapenem selection in stewardship strategies: a prospective propensity score-matched study of ertapenem versus class 2 carbapenems for empirical treatment of third-generation cephalosporin-resistant Enterobacterales bacteraemia. J Antimicrob Chemother. 2023 Jul 5;78(7):1748-1756. doi: 10.1093/jac/dkad165.
- 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 and Infection, Bacterial, 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 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
30-day mortality (time frame: 30 days). 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 NCT03925402, 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 29 Mar 2023.