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Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894046
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Entasis Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Acinetobacter Baumannii-calcoaceticus Complex Hospital-acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia Bacteremia Colistin Resistant ABC Drug: ETX2514/Sulbactam + Imipenem/Cilastin Drug: Colistin + Imipenem/Cilastin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: 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
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : July 19, 2020
Estimated Study Completion Date : July 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population) [ Time Frame: 28 Days ]
    The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.

  2. MITT (Modified Intent To Treat population containing all patients who received any amount of study drug) [ Time Frame: 28 days ]
    The primary safety endpoint for the study is the incidence of nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894046


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

Locations
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Sponsors and Collaborators
Entasis Therapeutics

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Responsible Party: Entasis Therapeutics
ClinicalTrials.gov Identifier: NCT03894046    
Other Study ID Numbers: CS2514-2017-0004
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacteremia
Pneumonia, Bacterial
Pneumonia
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Colistin
Imipenem
Sulbactam
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action