complicated Intra-Abdominal Infections (cIAI) MedDRA version: 20.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: LYS228
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not established
CAS Number: N/A
Current
commercially available piperacillin/tazobactam
locally sourced
Product Name: Piperacillin/tazobactam
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Piperacillin
commercially available vancomycin
locally sourced
Product Name: Vancomycin (INN)
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: VANCOMYCIN
commercially available metronidazole
locally sourced
Product Name: Metronidazole (INN)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: METRONIDAZOLE
Other de
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients 18 to 65 years of age, and after interim analysis of 8 patients, patients up to 70 years of age, inclusive, 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. Other protocol defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 nonstudy 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. - Non-abdominal bacterial infection diagnosed within 7 days prior to enrollment, including endocarditis, osteomyelitis, abscess, meningitis, or pneumonia . - Patient has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30 or is considered, in the judgment 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. Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the plasma pharmacokinetics of LYS228 in patients with cIAI - To evaluate the clinical response to LYS228 in combination with vancomycin and metronidazole compared to standard of care antibiotics for treating patients with cIAI ; Secondary Objective: - To evaluate the safety and tolerability of LYS228 in combination with vancomycin and metronidazole in patients with cIAI - To evaluate the microbiological response to LYS228 in combination with vancomycin and metronidazole compared to standard of care antibiotics for treating patients with cIAI ; Primary end point(s): - Clinical success at 28 days after randomization (End of Study) determined by signs, symptoms, and the need for additional antibiotics, unplanned surgical procedures, or drainage. - Plasma PK on Day 5 ; Timepoint(s) of evaluation of this end point: - Baseline, Day 28 - Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events, clinical laboratory tests, vital signs - Microbiologic success at 28 days after randomization (End of Study) determined by culture from the intra-abdominal focus of infection when available or presumed eradication based on clinical success ; Timepoint(s) of evaluation of this end point: - Daily - Baseline, day 28 | — |
Countries
Czech Republic, Germany, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o.
Outcome results
None listed