NCT07089186 Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
| NCT ID | NCT07089186 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Hospital-acquired Bacterial Pneumonia (HABP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2025-04-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07089186 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hospital-acquired Bacterial Pneumonia (HABP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07089186 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT07089186 currently recruiting?
Yes, NCT07089186 is actively recruiting participants. Contact the research team at Huanghaihui73@aliyun.com for enrollment information.
Where is the NCT07089186 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07089186 clinical trial?
NCT07089186 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 80 participants.