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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03894046
Other study ID # CS2514-2017-0004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 5, 2019
Est. completion date July 26, 2021

Study information

Verified date January 2023
Source Entasis Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date July 26, 2021
Est. primary completion date July 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: PART A 1. A confirmed diagnosis of a serious infection that will require treatment with IV antibiotics; 2. 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: 1. Has received no more than 48 hrs of potentially effective (ie, Gram negative coverage) antimicrobial therapy prior to the first dose of study drug; 2. Is clinically failing prior treatment regimens 3. APACHE II score 10 and 30 inclusive, or SOFA score between 7 and 11 inclusive, at time of diagnosis 4. 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 5. 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); 1. Known to be resistant to colistin or polymyxin B; or 2. Known intolerance to colistin; or 3. Has myasthenia gravis or another neuromuscular syndrome(s) that contraindicates colistin and is not ventilated; or 4. Has acute kidney injury and is receiving renal replacement therapy at study entry. Exclusion Criteria: 1. Evidence of active concurrent pneumonia requiring additional antimicrobial treatment 2. 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; 3. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) = 60 mmHg; 4. Pregnant or breastfeeding women; 5. Receiving peritoneal dialysis; 6. Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study; 7. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sulbactam
1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).
Durlobactam
1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h). Sulbactam-Durlobactam: Treatment for 7 days up to 14 days if clinically indicated.
Colistin
Treatment for 7 days up to 14 days if clinically indicated.
Imipenem/Cilastatin 500 mg/500 mg
1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Treatment for 7 days up to 14 days if clinically indicated.

Locations

Country Name City State
Belarus Entasis Research Site Brest
Belarus Entasis Research Site Gomel
Belarus Entasis Research Site Grodno
Belarus Entasis Research Site Minsk
Brazil Entasis Research Site Belo Horizonte
Brazil Entasis Research Site Campinas
Brazil Entasis Research Site Porto Alegre
Brazil Entasis Research Site Salvador
Brazil Entasis Research Site Sao Jose do Rio Preto
China Entasis Research Site 1 Beijing
China Entasis Research Site 2 Beijing
China Entasis Research Site 3 Beijing
China Entasis Research Site Changsha
China Entasis Research Site Chongqing
China Entasis Research Site Guangzhou
China Entasis Research Site Hebei
China Entasis Research Site 1 Hefei
China Entasis Research Site 2 Hefei
China Entasis Research Site Hubei
China Entasis Research Site Nanchang
China Entasis Research Site Nanjing
China Entasis Research Site Nanning
China Entasis Research Site 1 Shanghai
China Entasis Research Site 2 Shanghai
China Entasis Research Site Shenzhen
China Entasis Research Site Tianjin
China Entasis Research Site Wuhan
Greece Entasis Research Site 1 Athens
Greece Entasis Research Site 3 Athens
Greece Entasis Research Site Heraklion
Greece Entasis Research Site Larisa
Greece Entasis Research Site Larissa
Greece Entasis Research Site Thessaloniki
Hungary Entasis Research Site 1 Budapest
Hungary Entasis Research Site 2 Budapest
Hungary Entasis Research Site Debrecen
India Entasis Research Site Ahmedabad
India Entasis Research Site Belgaum
India Entasis Research Site 1 Gujrat
India Entasis Research Site 2 Gujrat
India Entasis Research Site Hyderabad
India Entasis Research Site Kolkata
India Entasis Research Site Pune
Israel Entasis Research Site Holon
Israel Entasis Research Site Tel Aviv
Israel Entasis Research Site Tel Hashomer
Israel Entasis Research Site Zerifin
Korea, Republic of Entasis Research Site Gyeonggi-do
Korea, Republic of Entasis Research Site 1 Seoul
Korea, Republic of Entasis Research Site 2 Seoul
Lithuania Entasis Research Site Kaunas
Lithuania Entasis Research Site Klaipeda
Lithuania Entasis Research Site Vilnius
Mexico Entasis Research Site 1 Guadalajara
Mexico Entasis Research Site 2 Guadalajara
Mexico Entasis Research Site Mexico DF
Mexico Entasis Research Site Monterrey
Mexico Entasis Research Site San Luis Potosi
Peru Entasis Research Site Bellavista
Peru Entasis Research Site Cusco
Peru Entasis Research Site Lima
Peru Entasis Research Site San Isidro
Peru Entasis Research Site San Martin de Porres
Puerto Rico Entasis Research Site Ponce
Russian Federation Entasis Research Site Arkhangelsk
Russian Federation Entasis Research Site Krasnodar
Russian Federation Entasis Research Site 1 Novosibirsk
Russian Federation Entasis Research Site 2 Novosibirsk
Russian Federation Entasis Research Site 3 Novosibirsk
Russian Federation Entasis Research Site Smolensk
Russian Federation Entasis Research Site 2 St Petersburg
Russian Federation Entasis Research Site 1 Tomsk
Russian Federation Entasis Research Site 2 Tomsk
Taiwan Entasis Research Site Kaohsiung
Taiwan Entasis Research Site Taichung
Taiwan Entasis Research Site Taipei
Taiwan Entasis Research Site Taipei City
Thailand Entasis Research Site Chiang Mai
Thailand Entasis Research Site Khon Kaen
Thailand Entasis Research Site Nakhon Ratchasima
Thailand Entasis Research Site Nonthaburi
Turkey Entasis Research Site 1 Ankara
Turkey Entasis Research Site 2 Ankara
Turkey Entasis Research Site Eskisehir
Turkey Entasis Research Site Kocaeli
Turkey Entasis Research Site Küçükçekmece
Turkey Entasis Research Site Trabzon
United States Entasis Research Site Chicago Illinois
United States Entasis Research Site Cincinnati Ohio
United States Entasis Research Site Houston Texas
United States Entasis Research Site Memphis Tennessee
United States Entasis Research Site Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Entasis Therapeutics

Countries where clinical trial is conducted

United States,  Belarus,  Brazil,  China,  Greece,  Hungary,  India,  Israel,  Korea, Republic of,  Lithuania,  Mexico,  Peru,  Puerto Rico,  Russian Federation,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A. 28 Days
Primary Proportion of Patients With Nephrotoxicity The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A. 28 days
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