Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections

NCT07089186 | Recruiting Phase 3

• 1 other identifier: FL058-302
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP); Complicated Intra-abdominal Infection (cIAI); Complicated Urinary Tract Infection (cUTI); Bloodstream Infection (BSI)

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]

  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]

  Day 28

• Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]

  at Test of Cure (TOC) visit (Day 10-23

Study Arms (2)

Meropenem and Pralurbactam

EXPERIMENTAL

Meropenem and Pralurbactam (180min infusion)

Drug: Meropenem and Pralurbactam

Best Available Therapy

ACTIVE COMPARATOR

Subjects will receive Best Available Therapy (IV antibiotics)

Drug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)

Interventions

Meropenem and Pralurbactam DRUG

3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)

Meropenem and Pralurbactam

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.

Best Available Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan Universit

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Meropenem; Colistin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Central Study Contacts

Haihui Huang, PhD

CONTACT

021-52888195; Huanghaihui73@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 28, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-06

Locations

CN (1)