NCT07327619 A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
| NCT ID | NCT07327619 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 420 participants in total. It began in 2026-01-22 with a primary completion date of 2028-06.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07327619 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 and Ventilator-associated Bacterial Pneumonia. 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 NCT07327619 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 420 participants.
Is NCT07327619 currently recruiting?
Yes, NCT07327619 is actively recruiting participants. Contact the research team at caobin_ben@163.com for enrollment information.
Where is the NCT07327619 trial being conducted?
This trial is being conducted at Huaihua, China.
Who is sponsoring the NCT07327619 clinical trial?
NCT07327619 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 420 participants.