Clinical Trials List
Protocol NumberCS2514-2017-0004
NCT Number(ClinicalTrials.gov Identfier)NCT03894046
2019-05-01 - 2021-12-30
Phase III
Recruiting2
Terminated2
ICD-10B96.89
Other specified bacterial agents as the cause of diseases classified elsewhere
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
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Entasis Therapeutics
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Zhi-Yu Chen Division of Thoracic Medicine
- 沈宜成 Division of Thoracic Medicine
- 曾皓陽 Division of Thoracic Medicine
- 陳韋成 Division of Thoracic Medicine
- 梁信杰 Division of Thoracic Medicine
- Bing-Ru Wu Division of Thoracic Medicine
- 沈孟芳 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 潘聖衛 Division of Thoracic Medicine
- Hsin-Kuo Ko Division of Thoracic Medicine
- Kang-Cheng Su Division of Thoracic Medicine
- 莊凡毅 Division of Thoracic Medicine
- 陳燕溫 Division of Thoracic Medicine
- 周中偉 Division of Thoracic Medicine
- KUANG-YAO YANG Division of Thoracic Medicine
- 蕭逸函 Division of Thoracic Medicine
- 何莉櫻 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-An Chang Division of Thoracic Medicine
- Po-Liang Lu Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- Shang-Yi Lin Division of Thoracic Medicine
- 陳家閔 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHUN-TA HUANG Division of General Internal Medicine
- 阮聖元 Division of General Internal Medicine
- HUI-FU HUANG Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
Objectives
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC 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 or polymyxin B treatment, as detailed in the inclusion criteria.
Primary Objectives
The primary objectives of this study are the following:
To compare the efficacy of ETX2514SUL plus imipenem/cilastatin to colistin plus
imipenem/cilastatin in patients with CRABC infections in Part A; and
To compare the incidence of nephrotoxicity, as measured by the Risk–Injury–Failure–Loss–
End-stage renal disease (RIFLE) criteria, of ETX2514SUL to colistin in patients with ABC infections in Part A.
Test Drug
Sulbactam-ETX2514 (ETX2514SUL)
Active Ingredient
ETX2514
Sulbactam
Sulbactam
Dosage Form
IVT
IVT
IVT
Dosage
ETX2514 powder 500 mg/bottle
Sulbactam powder 1 g/bottle
Sulbactam powder 1 g/bottle
Endpoints
Primary Outcome Measures :
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.
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.
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.
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.
Inclution Criteria
Inclusion Criteria:
PART A
A confirmed diagnosis of a serious infection that will require treatment with IV antibiotics;
A known infection caused by ABC (bacteremia, HABP, VABP, VP, 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/VP patients), AND 1 of the following:
Has received no more than 48 hrs of potentially effective (ie, Gram negative coverage) antimicrobial therapy prior to the first dose of study drug;
Is clinically failing prior treatment regimens
APACHE II score 10 and 30 inclusive, or SOFA score between 7 and 11 inclusive, at time of diagnosis
Expectation, in the judgment of the Investigator, that the patient will benefit from effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study
Women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug.
PART B
1. Has an infection (HABP, VABP, VP, bacteremia, cUTI, AP, or surgical or post-traumatic wound infections) caused by ABC organisms known to be resistant to colistin (defined as MIC ≥4 mg/L by a non-agar based method);
Known to be resistant to colistin or polymyxin B; or
Known intolerance to colistin; or
Has myasthenia gravis or another neuromuscular syndrome(s) that contraindicates colistin and is not ventilated; or
Has acute kidney injury and is receiving renal replacement therapy at study entry.
PART A
A confirmed diagnosis of a serious infection that will require treatment with IV antibiotics;
A known infection caused by ABC (bacteremia, HABP, VABP, VP, 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/VP patients), AND 1 of the following:
Has received no more than 48 hrs of potentially effective (ie, Gram negative coverage) antimicrobial therapy prior to the first dose of study drug;
Is clinically failing prior treatment regimens
APACHE II score 10 and 30 inclusive, or SOFA score between 7 and 11 inclusive, at time of diagnosis
Expectation, in the judgment of the Investigator, that the patient will benefit from effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study
Women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug.
PART B
1. Has an infection (HABP, VABP, VP, bacteremia, cUTI, AP, or surgical or post-traumatic wound infections) caused by ABC organisms known to be resistant to colistin (defined as MIC ≥4 mg/L by a non-agar based method);
Known to be resistant to colistin or polymyxin B; or
Known intolerance to colistin; or
Has myasthenia gravis or another neuromuscular syndrome(s) that contraindicates colistin and is not ventilated; or
Has acute kidney injury and is receiving renal replacement therapy at study entry.
Exclusion Criteria
Exclusion Criteria:
Evidence of active concurrent pneumonia requiring additional antimicrobial treatment
Presence of suspected or confirmed deep seated bacterial infections such as bacterial Gram negative osteomyelitis, endocarditis, or meningitis requiring prolonged therapy, as determined by history and/or physical examination;
Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 60 mmHg;
Pregnant or breastfeeding women;
Receiving peritoneal dialysis;
Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study;
Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy;
Evidence of active concurrent pneumonia requiring additional antimicrobial treatment
Presence of suspected or confirmed deep seated bacterial infections such as bacterial Gram negative osteomyelitis, endocarditis, or meningitis requiring prolonged therapy, as determined by history and/or physical examination;
Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 60 mmHg;
Pregnant or breastfeeding women;
Receiving peritoneal dialysis;
Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study;
Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy;
The Estimated Number of Participants
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Taiwan
40 participants
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Global
200 participants
