Carbapenem-Resistant Enterobacteriaceae InfectionNCT05850871
Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies
A study testing CAZ/AVI plus Aztreonam and Conventional treatment in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- CAZ/AVI plus Aztreonam and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2023to 31 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects clinically suspected of infection caused by Enterobacterales
- Subjects with bloodstream infection by MBL-producing Enterobacterales
Who cannot join
- Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
- subjects who are unwilling to enter the research group
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mingju Hao
Jinan, Shandong, 250014
Mingju Hao, +8613012995730, haomingju@163.com
About this study
Official title: Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes
The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes
Read the detailed description
Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.
The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.
- Being tested
- CAZ/AVI plus Aztreonam, Conventional treatment
- Keywords
- carbapenem resistance, Enterobacteriaceae, CRISPR/Cas9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAZ/AVI plus AztreonamDrug
Also called ceftzadime avibactam, aztreonam
Samples of the patients will be examined such as the routine blood test, blood culture et al.
Conventional treatmentOther
Conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| CAZ/AVI plus Aztreonam | Experimental | CAZ-AVI was administered at the dose of 2.5 g every 8 hours and ATM at the dose of 2 g every 8 hours Receives: Drug: CAZ/AVI plus Aztreonam |
| Conventional treatment | Active comparator | Other active antibiotics were administered, including colistin, tigecycline, fosfomycin, meropenem. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
The primary outcome measure was 30-day all-cause mortality
Measured: two years
clinical failure at day 14
severe comorbidities, mechanical ventilation or septic shock at day 14
Measured: two years
length of stay after diagnosis
length of stay (LOS) after blood stream infection diagnosis
Measured: two years
Secondary outcomes (1)
Positive rate of Metallo-β-lactamases (MBL) producing Enterobacterales
Positive rate and subtype distribution of Metallo-β-lactamases (MBL) producing Enterobacterales
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start6 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 427 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingju Hao, Qianfoshan Hospital
- Investigators
- Jiasheng Zhang, Doctor, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850871
- Sponsor's protocol ID
- JNQH-CT-231001
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes
- ClinicalTrials.gov ID
- NCT05850871
- Acronym / sponsor ID
- JNQH-CT-231001
- Keywords
- carbapenem resistance, Enterobacteriaceae, CRISPR/Cas9
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 427 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 May 2023 (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.
The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes
Detailed description
Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.
The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAZ/AVI plus Aztreonam | Experimental | Drug: CAZ/AVI plus AztreonamCAZ-AVI was administered at the dose of 2.5 g every 8 hours and ATM at the dose of 2 g every 8 hours |
| Conventional treatment | Active comparator | Other: Conventional treatmentOther active antibiotics were administered, including colistin, tigecycline, fosfomycin, meropenem. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects clinically suspected of infection caused by Enterobacterales
- Subjects with bloodstream infection by MBL-producing Enterobacterales
Key exclusion criteria (2 listed)
- Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
- subjects who are unwilling to enter the research group
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 |
|---|---|---|
| CAZ/AVI plus AztreonamAlso: ceftzadime avibactam, aztreonamSamples of the patients will be examined such as the routine blood test, blood culture et al. | Drug | CAZ/AVI plus Aztreonam |
| Conventional treatmentConventional treatment | Other | Conventional treatment |
Primary outcome
30-day all-cause mortality
Time frame: two years
The primary outcome measure was 30-day all-cause mortality
clinical failure at day 14
Time frame: two years
severe comorbidities, mechanical ventilation or septic shock at day 14
length of stay after diagnosis
Time frame: two years
length of stay (LOS) after blood stream infection diagnosis
1 secondary outcome
Positive rate of Metallo-β-lactamases (MBL) producing Enterobacterales
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
Jiasheng Zhang, Doctor study director
Shandong First Medical 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 CAZ/AVI plus Aztreonam and Conventional treatment in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Qianfoshan Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 9 May 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 China. 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 Mingju Hao, Doctor (8613012995730, haomingju@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: two years). The study lists 3 primary outcomes in all. 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 9 May 2023.