ECMONCT06210542
Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
An observational study of ECMO and Carbapenem-Resistant Enterobacteriaceae Infection, run by Sichuan Provincial People's Hospital.
Trial summary
The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ECMO, Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- ceftazidime avibactam
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients in ICU with CRO infections (including dialysis patients and ECMO patients).
Who may be able to join
- 18-85 years old.
- Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
- Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
- at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
- sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
- intravenous injection of Ceftazidime Avibactam for more than 72 hours.
- understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.
Who cannot join
- Participants are less than 18.
- Death within 72 hours after the start of treatment.
- Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
- No indication for treatment with ceftazidime avibactam.
- Pregnant and lactating women.
About this study
The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).
Read the detailed description
This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
- Being tested
- ceftazidime avibactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime avibactamDrug
Routine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) \> 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours.
Patients with renal injury adjust the dosage according to eCrCL
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate at the end of treatment and/or the time transfer out of ICU
Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
Microbiologic success rate at the end of treatment and/or the time transfer out of ICU
Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
Secondary outcomes (7)
All-cause mortality on day 28 after drug initiation
All-cause mortality refers to the proportion of the total number of deaths caused by various causes within a certain period to the total analyzed population. It is necessary to count the number of deaths caused by various causes during this period as of the 28th day after the start of medication, using the Clopper-Pearson method. Calculate the 95% confidence interval for all-cause mortality on day 28 after drug initiation.
Measured: 28 days from drug initiation
Infection-related mortality during hospitalization in ICU
The proportion of patients who died due to infection to the total analyzed population was calculated using the Clopper-Pearson method to calculate the 95% confidence interval for infection-related mortality. It should be noted that in-hospital deaths that occur after infection symptoms improve are not considered to be related to the infection.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
All-cause mortality on 90 days after drug initiation
As of the 90th day after the start of medication, the number of deaths due to various causes during this time period accounted for the proportion of the total population analyzed.
Measured: 90 days from drug initiation
Recurrence rate of infection on day 28 after starting medication
As of the 28th day after the start of medication, the number of people whose infection was controlled and then relapsed during this time period accounted for the proportion of the total analyzed population.
Measured: 28 days from drug initiation
Length of ICU Stay
Length of stay in ICU = date of discharge from ICU - date of admission to ICU + 1.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
Length of Hospital Stay (LOS)
Length of stay = discharge date - admission date + 1.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
Time from ceftazidime-avibactam treatment initiation to symptom improvement
As an indicator of time event type, the clinical outcome of the patients was marked as the end event of symptom improvement, and the patients who did not achieve symptom improvement at the observation deadline were marked as deletion. The median value and 95% confidence interval were estimated by Kaplan-Meier method.
Measured: the end of treatment or the time transfer out of ICU,up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210542
- Sponsor's protocol ID
- LPan20230579
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
- ClinicalTrials.gov ID
- NCT06210542
- Acronym / sponsor ID
- LPan20230579
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2024 (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 goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).
Detailed description
This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients in ICU with CRO infections (including dialysis patients and ECMO patients).
Key inclusion criteria (7 listed)
- 18-85 years old.
- Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
- Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
- at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
- sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
Key exclusion criteria (5 listed)
- Participants are less than 18.
- Death within 72 hours after the start of treatment.
- Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
- No indication for treatment with ceftazidime avibactam.
- Pregnant and lactating women.
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 |
|---|---|---|
| ceftazidime avibactamRoutine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) \> 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours. Patients with renal injury adjust the dosage according to eCrCL | Drug | – |
Primary outcome
Clinical success rate at the end of treatment and/or the time transfer out of ICU
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed.
Microbiologic success rate at the end of treatment and/or the time transfer out of ICU
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population.
7 secondary outcomes
All-cause mortality on day 28 after drug initiation
Time frame: 28 days from drug initiation
Infection-related mortality during hospitalization in ICU
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
All-cause mortality on 90 days after drug initiation
Time frame: 90 days from drug initiation
Recurrence rate of infection on day 28 after starting medication
Time frame: 28 days from drug initiation
Length of ICU Stay
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
Length of Hospital Stay (LOS)
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
Time from ceftazidime-avibactam treatment initiation to symptom improvement
Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ECMO and Carbapenem-Resistant Enterobacteriaceae Infection, run by Sichuan Provincial People's Hospital.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical success rate at the end of treatment and/or the time transfer out of ICU (time frame: the end of treatment or the time transfer out of ICU,up to 1 year.). The study lists 2 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 18 Jan 2024.