Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial PneumoniaPhase 3NCT07327619
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
A Phase 3 study testing Meropenem and Pralurbactam and Ceftazidime-avibactam in people with Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
- What is being tested?
- Meropenem and Pralurbactam and Ceftazidime-avibactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2026to Oct 2028
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female participants ≥18 and ≤80 years of age
- 2. have a diagnosis of HAP/VAP.
- 3. have systemic signs and respiratory signs or symptoms of HAP/VAP.
- 4. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
- 5. The estimated survival time is at lest 28 days.
Who cannot join
- 1. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
- 2. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
- 3. Acute Physiology and Chronic Health Evaluation (APACHE) II score >30.
- 4. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
- 5. Those who have a history of drug abuse or drug abuse within 6 months before screening.
- 6. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
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
Hunan University Of Medicine General Hospital
Huaihua, Hunan, 418000
jianliang Zhou, master, 0745-2383818, 82125817@qq.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.
- Being tested
- Meropenem and Pralurbactam, Ceftazidime-avibactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem and PralurbactamDrug
3g，q8h，120min infusion
Ceftazidime-avibactamDrug
2.5g，q8h，120min infusion
| Study group | Role | What they receive |
|---|---|---|
| Meropenem and Pralurbactam | Experimental | Not described Receives: Drug: Meropenem and Pralurbactam |
| Ceftazidime-avibactam | Active comparator | Not described Receives: Drug: Ceftazidime-avibactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start22 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327619
- Sponsor's protocol ID
- FL058-303
- Status last verified
- Sep 2025
- First submitted
- 26 Dec 2025
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT07327619
- Acronym / sponsor ID
- FL058-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jan 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.
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem and Pralurbactam | Experimental | Drug: Meropenem and Pralurbactam |
| Ceftazidime-avibactam | Active comparator | Drug: Ceftazidime-avibactam |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male or female participants ≥18 and ≤80 years of age
- 2. have a diagnosis of HAP/VAP.
- 3. have systemic signs and respiratory signs or symptoms of HAP/VAP.
- 4. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
- 5. The estimated survival time is at lest 28 days.
Key exclusion criteria (6 listed)
- 1. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
- 2. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
- 3. Acute Physiology and Chronic Health Evaluation (APACHE) II score >30.
- 4. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
- 5. Those who have a history of drug abuse or drug abuse within 6 months before screening.
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 |
|---|---|---|
| Meropenem and Pralurbactam3g，q8h，120min infusion | Drug | Meropenem and Pralurbactam |
| Ceftazidime-avibactam2.5g，q8h，120min infusion | Drug | Ceftazidime-avibactam |
Primary outcome
Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT
Time frame: Day 14
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 Feb 2026.
Related trials for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingPhase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
RecruitingPhase 2
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
Recruiting
Impact of BioFire FilmArray Pneumonia Panel vs Routine Diagnostics on Antimicrobial Outcomes (DOOR-MAT)
Pneumonia - Bacterial
RecruitingPhase 2
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia
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 3 study testing Meropenem and Pralurbactam and Ceftazidime-avibactam in people with Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia, run by Qilu Pharmaceutical Co., Ltd. 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 5 inclusion and 6 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 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Bin Cao, PhD (010 8420 6266, caobin_ben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT (time frame: Day 14). 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 Feb 2026.