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

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

September 5, 2019

Primary Completion Date

July 26, 2021

Study Completion Date

July 26, 2021

Conditions
Acinetobacter Baumannii-calcoaceticus ComplexHospital-acquired Bacterial PneumoniaVentilator-associated Bacterial PneumoniaBacteremiaColistin Resistant ABC
Interventions
DRUG

Sulbactam

1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).

DRUG

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."

DRUG

Colistin

Treatment for 7 days up to 14 days if clinically indicated.

DRUG

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.

Trial Locations (90)

38163

Entasis Research Site, Memphis

45219

Entasis Research Site, Cincinnati

60611

Entasis Research Site, Chicago

71101

Entasis Research Site, Shreveport

77030

Entasis Research Site, Houston

192242

Entasis Research Site 2, Saint Petersburg

395002

Entasis Research Site 1, Gujrāt

Unknown

Entasis Research Site, Brest

Entasis Research Site, Grodno

Entasis Research Site, Homyel

Entasis Research Site, Minsk

Entasis Research Site, Belo Horizonte

Entasis Research Site, Campinas

Entasis Research Site, Porto Alegre

Entasis Research Site, Salvador

Entasis Research Site, São José do Rio Preto

Entasis Research Site 1, Beijing

Entasis Research Site 2, Beijing

Entasis Research Site 3, Beijing

Entasis Research Site, Changsha

Entasis Research Site, Chongqing

Entasis Research Site, Guangzhou

Entasis Research Site, Hebei

Entasis Research Site 1, Hefei

Entasis Research Site 2, Hefei

Entasis Research Site, Hubei

Entasis Research Site, Nanchang

Entasis Research Site, Nanjing

Entasis Research Site, Nanning

Entasis Research Site 1, Shanghai

Entasis Research Site 2, Shanghai

Entasis Research Site, Shenzhen

Entasis Research Site, Tianjin

Entasis Research Site, Wuhan

Entasis Research Site 1, Athens

Entasis Research Site 3, Athens

Entasis Research Site, Heraklion

Entasis Research Site, Larissa

Entasis Research Site, Thessaloniki

Entasis Research Site 1, Budapest

Entasis Research Site 2, Budapest

Entasis Research Site, Debrecen

Entasis Research Site, Ahmedabad

Entasis Research Site, Belagavi

Entasis Research Site, Hyderabad

Entasis Research Site, Kolkata

Entasis Research Site, Pune

Entasis Research Site, Holon

Entasis Research Site, Tel Aviv

Entasis Research Site, Tel Litwinsky

Entasis Research Site, Ẕerifin

Entasis Research Site, Kaunas

Entasis Research Site, Klaipėda

Entasis Research Site, Vilnius

Entasis Research Site 1, Guadalajara

Entasis Research Site 2, Guadalajara

Entasis Research Site, Mexico City

Entasis Research Site, Monterrey

Entasis Research Site, San Luis Potosí City

Entasis Research Site, Bellavista

Entasis Research Site, Cusco

Entasis Research Site, Lima

Entasis Research Site, San Isidro

Entasis Research Site, San Martín de Porres

Entasis Research Site, Ponce

Entasis Research Site, Arkhangelsk

Entasis Research Site, Krasnodar

Entasis Research Site 1, Novosibirsk

Entasis Research Site 2, Novosibirsk

Entasis Research Site 3, Novosibirsk

Entasis Research Site, Smolensk

Entasis Research Site 1, Tomsk

Entasis Research Site 2, Tomsk

Entasis Research Site, Gyeonggi-do

Entasis Research Site 1, Seoul

Entasis Research Site 2, Seoul

Entasis Research Site, Kaohsiung City

Entasis Research Site, Taichung

Entasis Research Site, Taipei

Entasis Research Site, Chiang Mai

Entasis Research Site, Khon Kaen

Entasis Research Site, Nakhon Ratchasima

Entasis Research Site, Nonthaburi

Entasis Research Site 1, Ankara

Entasis Research Site 2, Ankara

Entasis Research Site, Eskişehir

Entasis Research Site, Kocaeli

Entasis Research Site, Küçükçekmece

Entasis Research Site, Trabzon

382 428

Entasis Research Site 2, Gujrāt

Sponsors
All Listed Sponsors
lead

Entasis Therapeutics

INDUSTRY

NCT03894046 - Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex | Biotech Hunter | Biotech Hunter