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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

NCT03894046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-02-01

Study results available
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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.

Conditions

  • Acinetobacter Baumannii-calcoaceticus Complex
  • Hospital-acquired Bacterial Pneumonia
  • Ventilator-associated Bacterial Pneumonia
  • Bacteremia
  • Colistin 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.

Sponsors & Collaborators

  • Entasis Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2021-07-26
Completion
2021-07-26
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Brazil
  • China
  • Greece
  • Hungary
  • India
  • Israel
  • Lithuania
  • Mexico
  • Peru
  • Puerto Rico
  • Russia
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894046 on ClinicalTrials.gov