Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC (Acinetobacter baumannii-calcoaceticus Complex) hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin treatment.

Official Title

A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

Keywords

Acinetobacter Baumannii-calcoaceticus Complex Hospital-acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia Bacteremia Colistin Resistant ABC Pneumonia, Bacterial Pneumonia Colistin Imipenem Sulbactam ETX2514/Sulbactam + Imipenem/Cilastin Colistin + Imipenem/Cilastin

Eligibility

For people ages 18 years and up

Inclusion Criteria:

PART A

  1. A confirmed diagnosis of a serious infection and the expectation, in the judgment of the Investigator, that the patient's infection will require treatment with IV antibiotics;
  2. A known infection caused by ABC (bacteremia, HABP, VABP, cUTI or AP, or surgical or post-traumatic wound infections) as either a single pathogen or member of a polymicrobial infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP patients), AND 1 of the following: a. Has received no more than 48 hours of effective empiric therapy prior to enrollment; OR b. Is clinically failing prior treatment regimens
  3. Expectation, in the judgment of the Investigator, that the patient will survive at least 72 hours with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study
  4. Women of childbearing potential
  5. Male participants must be willing to use condoms during sexual intercourse from Screening until at least 90 days after administration of the last dose of study drug.

PART B

  1. Has an infection caused by ABC organisms known to be resistant to colistin (defined as

MIC 4 mg/L by a non-agar based method); For known colistin-resistant infections, the following must be satisfied:

  1. Has a known resistant infection based on evidence from culture and susceptibility OR
  2. Has documented clinical evidence of failure
  3. Known intolerance to colistin;
  4. Has myasthenia gravis or is taking curariform muscle relaxants (eg, tubocurarine) or other drugs that potentiate neuromuscular blocking, including ether, succinylcholine, gallamine, decamethonium, and sodium citrate and, hence, cannot receive colistin; OR
  5. Has acute kidney injury and is receiving renal replacement therapy at study entry.

Locations

  • University of California - Davis not yet accepting patients
    Sacramento California 95817 United States
  • University of Texas Southwestern Medical Center not yet accepting patients
    Dallas Texas 75390 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Entasis Therapeutics
Links
Sign up for this study
ID
NCT03894046
Phase
Phase 3
Study Type
Interventional
Last Updated