Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: Sulbactam-ETX2514; Placebo; Imipenem-cilastatin
Intervention description: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.; Matching 1g IV solution.; All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
Intervention MeSH terms: Imipenem; Sulbactam; Cilastatin, Imipenem Drug Combination; Durlobactam; Cilastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and
      efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who
      are otherwise relatively healthy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed informed consent form (ICF). If a study patient is unable to provide informed
             consent due to their medical condition, the patient's legally authorized
             representative may consent on behalf of the study patient as permitted by local law
             and institutional Standard Operating Procedures.

          -  Male or female, 18 to 90 years of age, inclusive.

          -  Expectation, in the judgment of the Investigator, that the patient's cUTI would
             require initial hospitalization and treatment with IV antibiotics.

          -  Documented or suspected cUTI or Acute pyelonephritis (AP).

        Exclusion Criteria:

          -  Gross hematuria requiring intervention other than administration of study drug or
             removal or exchange of a urinary catheter.

          -  Known non-renal source of infection such as endocarditis, osteomyelitis, abscess,
             meningitis, or pneumonia diagnosed within 7 days prior to randomization that would
             interfere with evaluation of response to the study antibiotics.

          -  Patient requires continuing treatment with probenecid, methotrexate, ganciclovir,
             valproic acid, or divalproex sodium during the study.

          -  Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic
             with activity against Gram-negative uropathogens for more than 24 hours within the
             72-hour window prior to randomization.

          -  Requirement at time of randomization for any reason for additional systemic
             antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal
             therapy) other than study drug, with the exception of a single oral dose of any
             antifungal treatment for vaginal candidiasis.

          -  Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the
             patient's participation in the study [from randomization through the Late Follow-up
             (LFU) Visit].

          -  Any patients previously randomized in this study.