Hospital-acquired Bacterial Pneumonia (HABP)Phase 3NCT07089186
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
A Phase 3 study testing Meropenem and Pralurbactam and Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) in people with Hospital-acquired Bacterial Pneumonia (HABP) and Ventilator-associated Bacterial Pneumonia (VABP), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI)
- What is being tested?
- Meropenem and Pralurbactam and Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2025to Apr 2027
- 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
- Hospitalized male or female≥18 and ≤80 years of age，
- Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
- Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy
- The estimated survival time is more than 28 days
- Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form
Who cannot join
- Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
- Participant is expected to require more than 21 days of treatment
- Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 using the most recent available data
- Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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
Huashan Hospital, Fudan Universit
Shanghai
HuangHai Hui, 021-52888195, Huanghaihui73@aliyun.com
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Bloodstream Infection (BSI)
- Being tested
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem and PralurbactamDrug
3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)
Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)Drug
The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem and Pralurbactam | Experimental | Meropenem and Pralurbactam (180min infusion) Receives: Drug: Meropenem and Pralurbactam |
| Best Available Therapy | Active comparator | Subjects will receive Best Available Therapy (IV antibiotics) Receives: Drug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
Measured: at Test of Cure (TOC) visit (Day 12-23)
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]
Measured: Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]
Measured: at Test of Cure (TOC) visit (Day 10-23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start12 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (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 (HABP)Studies 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
- 80 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
- NCT07089186
- Sponsor's protocol ID
- FL058-302
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 30 Jul 2025
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections
- ClinicalTrials.gov ID
- NCT07089186
- Acronym / sponsor ID
- FL058-302
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Bloodstream Infection (BSI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jul 2025 (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 study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
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 PralurbactamMeropenem and Pralurbactam (180min infusion) |
| Best Available Therapy | Active comparator | Drug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)Subjects will receive Best Available Therapy (IV antibiotics) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized male or female≥18 and ≤80 years of age，
- Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
- Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy
- The estimated survival time is more than 28 days
- Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form
Key exclusion criteria (5 listed)
- Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
- Participant is expected to require more than 21 days of treatment
- Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 using the most recent available data
- Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices
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，180min infusion，Dose adjustments are available for participants with eGFR(mL/min) | Drug | Meropenem and Pralurbactam |
| Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam. | Drug | Best Available Therapy |
Primary outcome
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
Time frame: at Test of Cure (TOC) visit (Day 12-23)
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]
Time frame: Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]
Time frame: at Test of Cure (TOC) visit (Day 10-23
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 30 Jul 2025.
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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.
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 Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) in people with Hospital-acquired Bacterial Pneumonia (HABP) and Ventilator-associated Bacterial Pneumonia (VABP), 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 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 30 Jul 2025. 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 Haihui Huang, PhD (021-52888195, Huanghaihui73@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)] (time frame: at Test of Cure (TOC) visit (Day 12-23)). 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 30 Jul 2025.