Anti-Infective AgentPhase 4NCT06528028
Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes
A Phase 4 study testing CAZ/AVI in people with Anti-Infective Agent, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anti-Infective Agent
- What is being tested?
- CAZ/AVI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jul 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam
Who cannot join
- Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Drum Tower Hospital
Nanjing, Jiangsu, 210009
Ying Xu, Ph.D, +86 13809043146, ctboycm@hotmail.com
About this study
Official title: Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.
Read the detailed description
- Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function).
- Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions
- Conditions
- Anti-Infective Agent
- Being tested
- CAZ/AVI
- Keywords
- Anti-Infective Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAZ/AVIDrug
Also called Continous group
continuous infusion is used
CAZ/AVIDrug
Also called Intermittent group
2h-infusion is used
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.） loading dose of 2.5g (2h infusion), then the standard dose and administration schedule, namely 2.5gQ8h, continuous infusion, the dose can be adjusted according to the instructions of renal function，The duration of medication is determined by the clinician Receives: Drug: CAZ/AVI |
| control group | Experimental | Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.）were given a load dose of 2.5g (2h infusion), followed by 2.5gQ8h, the dose can be adjusted according to renal function.The duration of medication is determined by the clinician. Receives: Drug: CAZ/AVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effective rate
According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%.
Measured: 14 days
Secondary outcomes (3)
Bacterial removal
Defined as clearance or change of existing bacteria within two weeks of medication.
Measured: 14 days
28-d mortality
Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%.
Measured: 28 days
PK/PD compliance rate
PK/PD compliance rate = number of qualified persons/number of groups × 100%.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Infective AgentStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group and control group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Xu, Ph.D, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528028
- Sponsor's protocol ID
- EH3420202401
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06528028
- Acronym / sponsor ID
- EH3420202401
- Conditions
- Anti-Infective Agent
- Keywords
- Anti-Infective Agent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 30 Jul 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.
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.
Detailed description
- Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function).
- Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment group and control group
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: CAZ/AVICeftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.） loading dose of 2.5g (2h infusion), then the standard dose and administration schedule, namely 2.5gQ8h, continuous infusion, the dose can be adjusted according to the instructions of renal function，The duration of medication is determined by the clinician |
| control group | Experimental | Drug: CAZ/AVICeftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.）were given a load dose of 2.5g (2h infusion), followed by 2.5gQ8h, the dose can be adjusted according to renal function.The duration of medication is determined by the clinician. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam
Key exclusion criteria (1 listed)
- Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
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/AVIAlso: Continous groupcontinuous infusion is used | Drug | treatment group |
| CAZ/AVIAlso: Intermittent group2h-infusion is used | Drug | control group |
Primary outcome
Clinical effective rate
Time frame: 14 days
According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%.
3 secondary outcomes
Bacterial removal
Time frame: 14 days
28-d mortality
Time frame: 28 days
PK/PD compliance rate
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- 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.
Ying Xu, Ph.D principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CAZ/AVI in people with Anti-Infective Agent, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 1 inclusion and 1 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 30 Jul 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ying Xu, Ph.D (0086+（025）83106666, ctboycm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effective rate (time frame: 14 days). 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 30 Jul 2024.