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

NCT ID: NCT07089186

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-12
• Study Completion Date: 2027-04-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Meropenem and Pralurbactam

Meropenem and Pralurbactam (180min infusion)

Group Type: EXPERIMENTAL

Meropenem and Pralurbactam

Intervention Type: DRUG

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

Best Available Therapy

Subjects will receive Best Available Therapy (IV antibiotics)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.

Interventions

Meropenem and Pralurbactam

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan Universit

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Haihui Huang, PhD

Role: CONTACT

Huanghaihui73@aliyun.com

021-52888195

Facility Contacts

HuangHai Hui

Role: primary

Huanghaihui73@aliyun.com

021-52888195

Other Identifiers

FL058-302

Identifier Type: -

Identifier Source: org_study_id