Status:
TERMINATED
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Intra-abdominal Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03354754
Start Date
May 15 2018
End Date
September 24 2018
Last Update
October 11 2021
Active Locations (1)
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1
Novartis Investigative Site
Somers Point, New Jersey, United States, 08230