YS228 PK, clinical response, safety and tolerability in patients with complicated intra-abdominal infection (cIAI)
- Conditions
- Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]complicated Intra-Abdominal Infections (cIAI)MedDRA version: 20.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862
- Registration Number
- EUCTR2017-003130-90-CZ
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method