LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/22/2018 |
| Start Date: | May 15, 2018 |
| End Date: | September 24, 2018 |
A Randomized, Controlled, Evaluator-blinded, Multi-center Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety, and Tolerability in Patients With Complicated Intra-abdominal Infection
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of
complicated intra-abdominal infections.
LYS228 exposure across patients with varying renal function will be evaluated during the
study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient
population. The PK exposure of the initial 8 patients will be analyzed. A second PK analysis
with 20 patients will be conducted. This will enable an emerging data review of the required
doses for patients in each renal function category and adjustment as necessary.
complicated intra-abdominal infections.
LYS228 exposure across patients with varying renal function will be evaluated during the
study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient
population. The PK exposure of the initial 8 patients will be analyzed. A second PK analysis
with 20 patients will be conducted. This will enable an emerging data review of the required
doses for patients in each renal function category and adjustment as necessary.
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.
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