Ceftazidime-avibactamPhase 4NCT07478484
Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB
A Phase 4 study testing ceftazidime-avibactam combined with aztreonam in people with Ceftazidime-avibactam and Aztreonam, run by Jing Zhou at 1 site in China.
Trial summary
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ceftazidime-avibactam, Aztreonam, Gram-negative Bacterial Infection
- What is being tested?
- ceftazidime-avibactam combined with aztreonam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Jan 2028
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with complicated intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), or bloodstream infection (BSI);
- Patients with confirmed infections caused by metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), as determined by genotypic testing using next-generation sequencing (NGS) or carbapenem resistance gene testing;
- Patients receiving treatment with ceftazidime-avibactam in combination with aztreonam.
Who cannot join
- Patients aged under 18 years;
- Patients with known hypersensitivity to ceftazidime, avibactam, aztreonam, or any of the excipients; or those with a history of severe hypersensitivity reactions (e.g., anaphylactic shock, severe skin reactions) to any other β-lactam antibacterial agents (such as penicillins, monobactams, or carbapenems);
- Pregnant or breastfeeding women;
- Patients unable to comprehend or comply with the study protocol;
- Any other condition which, in the investigator's discretion, makes the patient unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jing Zhou
Nanjin, Jiangsu, 210000
Jing Zhou, 6830-5052, zhoujing1364@jsph.org.cn
About this study
Official title: A Clinical Study on Sequential Infusion Versus Concomitant Infusion of Ceftazidime-avibactam Combined With Aztreonam for the Treatment of Metallo-β-lactamase-producing Carbapenem-resistant Gram-negative Bacterial Infections.
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance. Current novel β-lactamase inhibitors (e.g., avibactam, relebactam, vaborbactam) only inhibit serine enzymes and are ineffective against metallo-β-lactamases (MBL), severely limiting clinical treatment options. Aztreonam (ATM) is inherently stable against MBL, while avibactam (AVI) inhibits co-produced serine β-lactamases (e.g., KPC, OXA-48). Their combination achieves complementary synergistic antibacterial effects. The ceftazidime-avibactam plus aztreonam (CZA+ATM) regimen, operating via the mechanism of "avibactam protecting aztreonam", has demonstrated synergistic bactericidal activity against NDM, VIM, IMP and other MBL-producers in multiple real-world and clinical studies, significantly reducing infection-related mortality.However, although current domestic and international guidelines recommend the CZA+ATM combination for MBL infections, there is no consensus on optimal infusion strategies. Based on the above, this study hypothesizes that in patients with complicated infections caused by MBL-producing CR-GNB, different infusion modalities of ceftazidime-avibactam combined with aztreonam-concomitant infusion versus sequential infusion-will show no significant differences in PK/PD target attainment rates, clinical cure rates, microbiological eradication rates, or all-cause mortality, without increasing the risk of adverse events.
- Conditions
- Ceftazidime-avibactam, Aztreonam, Gram-negative Bacterial Infection, Metallo-β-lactamase-producing, Carbapenem-resistant
- Being tested
- ceftazidime-avibactam combined with aztreonam
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime-avibactam combined with aztreonamDrug
Ceftazidime-avibactam 2.5g every 8 hours (q8h) administered as a 3-hour concomitant intravenous infusion with aztreonam 2g q8h, versus ceftazidime-avibactam 2.5g q8h infused over 2 hours followed by a 1-hour intravenous infusion of aztreonam
| Study group | Role | What they receive |
|---|---|---|
| concomitant infusion | Experimental | Not described Receives: Drug: ceftazidime-avibactam combined with aztreonam |
| sequential infusion | Active comparator | Not described Receives: Drug: ceftazidime-avibactam combined with aztreonam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Clinical cure at Day 14 of treatment
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 posted17 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ceftazidime-avibactamStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Zhou, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478484
- Sponsor's protocol ID
- 2026-SR-085
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Sequential Infusion Versus Concomitant Infusion of Ceftazidime-avibactam Combined With Aztreonam for the Treatment of Metallo-β-lactamase-producing Carbapenem-resistant Gram-negative Bacterial Infections.
- ClinicalTrials.gov ID
- NCT07478484
- Acronym / sponsor ID
- 2026-SR-085
- Conditions
- Ceftazidime-avibactam, Aztreonam, Gram-negative Bacterial Infection, Metallo-β-lactamase-producing, Carbapenem-resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jing ZhouUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 17 Mar 2026 (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.
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance. Current novel β-lactamase inhibitors (e.g., avibactam, relebactam, vaborbactam) only inhibit serine enzymes and are ineffective against metallo-β-lactamases (MBL), severely limiting clinical treatment options. Aztreonam (ATM) is inherently stable against MBL, while avibactam (AVI) inhibits co-produced serine β-lactamases (e.g., KPC, OXA-48). Their combination achieves complementary synergistic antibacterial effects. The ceftazidime-avibactam plus aztreonam (CZA+ATM) regimen, operating via the mechanism of "avibactam protecting aztreonam", has demonstrated synergistic bactericidal activity against NDM, VIM, IMP and other MBL-producers in multiple real-world and clinical studies, significantly reducing infection-related mortality.However, although current domestic and international guidelines recommend the CZA+ATM combination for MBL infections, there is no consensus on optimal infusion strategies. Based on the above, this study hypothesizes that in patients with complicated infections caused by MBL-producing CR-GNB, different infusion modalities of ceftazidime-avibactam combined with aztreonam-concomitant infusion versus sequential infusion-will show no significant differences in PK/PD target attainment rates, clinical cure rates, microbiological eradication rates, or all-cause mortality, without increasing the risk of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concomitant infusion | Experimental | Drug: ceftazidime-avibactam combined with aztreonam |
| sequential infusion | Active comparator | Drug: ceftazidime-avibactam combined with aztreonam |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with complicated intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), or bloodstream infection (BSI);
- Patients with confirmed infections caused by metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), as determined by genotypic testing using next-generation sequencing (NGS) or carbapenem resistance gene testing;
- Patients receiving treatment with ceftazidime-avibactam in combination with aztreonam.
Key exclusion criteria (5 listed)
- Patients aged under 18 years;
- Patients with known hypersensitivity to ceftazidime, avibactam, aztreonam, or any of the excipients; or those with a history of severe hypersensitivity reactions (e.g., anaphylactic shock, severe skin reactions) to any other β-lactam antibacterial agents (such as penicillins, monobactams, or carbapenems);
- Pregnant or breastfeeding women;
- Patients unable to comprehend or comply with the study protocol;
- Any other condition which, in the investigator's discretion, makes the patient unsuitable for participation in the trial.
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-avibactam combined with aztreonamCeftazidime-avibactam 2.5g every 8 hours (q8h) administered as a 3-hour concomitant intravenous infusion with aztreonam 2g q8h, versus ceftazidime-avibactam 2.5g q8h infused over 2 hours followed by a 1-hour intravenous infusion of aztreonam | Drug | concomitant infusion, sequential infusion |
Primary outcome
Clinical cure rate
Time frame: 14 days
Clinical cure at Day 14 of treatment
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 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ceftazidime-avibactam
Not yet recruitingObservational study
Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations
Ceftazidime-avibactam
Not yet recruitingObservational study
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
ISOLATION OF KLEB. by Culture on macConkey Agar, Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25
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.
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 ceftazidime-avibactam combined with aztreonam in people with Ceftazidime-avibactam and Aztreonam, run by Jing Zhou 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 3 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure 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 17 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.