LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
Condition: Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: LYS228; Standard of care therapy
Intervention description: LYS228 IV infusion every 6 hours; IV infusion of standard of care antibiotics
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: A blinded evaluator performed the safety and efficacy assessments
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Intra-abdominal infection; LYS228; beta-lactam antibiotics; creatinine clearance; enterobacteriaceae

Summary:

      The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of
      complicated intra-abdominal infections.

      It was planned that LYS228 exposure across patients with varying renal function would be
      evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate
      to treat the patient population. It was planned that the PK exposure of the initial 8
      patients would be analyzed.

      PK analysis was not conducted as per protocol the first analysis required 8 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 18 to 85 years of age with visual confirmation (presence of
             pus within the abdominal cavity) of an intra-abdominal infection associated with
             peritonitis including at least one inclusionary diagnosis during surgical
             intervention.

        Exclusion Criteria

          -  Any of the excluded diagnoses: abdominal wall abscess, small bowel obstruction,
             traumatic bowel perforation undergoing surgery within 12 hours, perforation of
             gastroduodenal ulcer with surgery within 24 hours, an intra-abdominal process that is
             not likely caused by infection.

          -  Pre-operative treatment of any duration with non-study Drug systemic antibiotic
             therapy for peritonitis or abscess is not allowed unless certain criteria are met.

          -  Concomitant bacterial infection at time of enrollment requiring non-Study Drug
             antibiotics and that may interfere with the evaluation of clinical response to the
             study antibiotic.

          -  Known non-abdominal source of infection, including endocarditis, osteomyelitis,
             abscess, meningitis, or pneumonia diagnosed within 7 days prior to enrollment.

          -  Patient has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score >
             30 or is considered, in the judgement of the investigator, unlikely to survive 4 weeks
             (e.g. rapidly progressive terminal illness, including septic shock).

          -  Patients that meet sepsis criteria as defined by the quick sequential sepsis-related
             organ failure assessment (qSOFA).

          -  Women of child-bearing potential unless they are using highly effective methods of
             contraception during dosing and for 7 days after stopping study treatment.