Acinetobacter Baumannii Infection Clinical Trial
Official title:
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion in participants with various degrees of renal impairment (RI), in participants with end-stage renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control participants with normal renal function.
This Phase 1, open-label, non-randomized study evaluates the PK, safety, and tolerability of
a single concurrent IV infusion of ETX2514SUL in participants with various degrees of RI, in
participants with ESRD who are on HD, and in healthy matched control participants with normal
renal function.
Participants will be enrolled into five cohorts, according to renal function status, and will
receive an IV infusion of ETX2514SUL (single dose of up to 1000 milligrams [mg] ETX2514 and
1000 mg sulbactam given by concurrent 3-hour IV infusion). Participants in Cohort 5 will
receive the ETX2514SUL infusion both post-HD (Period 1) and pre-HD (Period 2).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02971423 -
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02886637 -
Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection
|
N/A | |
| No longer available |
NCT04636554 -
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
|