Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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 ofthe 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Study drugs will not be masked due to logistical reasons, every attempt will be made to maintain the blind for patients, all staff at the site, and the Sponsor or its designees, except for the treatment physician and other immediate healthcare providers.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A
  • Drug: ETX2514/Sulbactam + Imipenem/Cilastin
    ETX2514/1.0 g sulbactam IV infused every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused every 6 hours(q6h)
  • Drug: Colistin + Imipenem/Cilastin
    2.5 mg/kg colistin IV infused every 12 hours (q12h) plus 1.0 g imipenem/1.0 g cilastatin IV infused every 6 hours (q6h).
Experimental
Part B
  • Drug: ETX2514/Sulbactam + Imipenem/Cilastin
    ETX2514/1.0 g sulbactam IV infused every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused every 6 hours(q6h)

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

NCT ID
NCT03894046
Status
Recruiting
Sponsor
Entasis Therapeutics

Study Contact

Chief Medical Officer
781-810-8940
Enquiries@entasistx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.