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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Meropenem and Pralurbactam
  • Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators