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Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

Primary Purpose

Complicated Urinary Tract Infection, Acute Pyelonephritis

Status

Completed

Phase

Phase 2

Locations

Bulgaria

Study Type

Interventional

Intervention

Sulbactam-ETX2514

Placebo

Imipenem-cilastatin

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operating Procedures.
Male or female, 18 to 90 years of age, inclusive.
Expectation, in the judgment of the Investigator, that the patient's cUTI would require initial hospitalization and treatment with IV antibiotics.
Documented or suspected cUTI or Acute pyelonephritis (AP).

Exclusion Criteria:

Gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter.
Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics.
Patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.
Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization.
Requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis.
Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the patient's participation in the study [from randomization through the Late Follow-up (LFU) Visit].
Any patients previously randomized in this study.

Sites / Locations

Universeity Multiprofile Hospital for Active Teatment
University Multiprofile Hospital for Active Teatment-Clinic of Nephrology
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

Placebo + Imipenem/Cilastatin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Overall Success

The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.

Secondary Outcome Measures

Clinical Cure

Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.

Microbiologic Eradication

Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit

Full Information

NCT ID

NCT03445195

First Posted

February 20, 2018

Last Updated

January 20, 2020

Sponsor

Entasis Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03445195

Brief Title

Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

Official Title

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

January 17, 2018 (Actual)

Primary Completion Date

May 17, 2018 (Actual)

Study Completion Date

May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Entasis Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

Detailed Description

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complicated Urinary Tract Infection, Acute Pyelonephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

Arm Type

Experimental

Arm Title

Placebo + Imipenem/Cilastatin

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Sulbactam-ETX2514

Other Intervention Name(s)

ETX2514SUL

Intervention Description

The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching 1g IV solution.

Intervention Type

Drug

Intervention Name(s)

Imipenem-cilastatin

Intervention Description

All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Primary Outcome Measure Information:

Title

Number of Participants With Overall Success

Description

Time Frame

From baseline through day 21

Secondary Outcome Measure Information:

Title

Clinical Cure

Description

Time Frame

Baseline to day 21

Title

Microbiologic Eradication

Description

Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit

Time Frame

Baseline to day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operating Procedures. Male or female, 18 to 90 years of age, inclusive. Expectation, in the judgment of the Investigator, that the patient's cUTI would require initial hospitalization and treatment with IV antibiotics. Documented or suspected cUTI or Acute pyelonephritis (AP). Exclusion Criteria: Gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics. Patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study. Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization. Requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis. Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the patient's participation in the study [from randomization through the Late Follow-up (LFU) Visit]. Any patients previously randomized in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anibal Calmaggi, MD

Organizational Affiliation

Medpace, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Universeity Multiprofile Hospital for Active Teatment

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Teatment-Clinic of Nephrology

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31843995

Citation

Sagan O, Yakubsevitch R, Yanev K, Fomkin R, Stone E, Hines D, O'Donnell J, Miller A, Isaacs R, Srinivasan S. Pharmacokinetics and Tolerability of Intravenous Sulbactam-Durlobactam with Imipenem-Cilastatin in Hospitalized Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01506-19. doi: 10.1128/AAC.01506-19. Print 2020 Feb 21.

Results Reference

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Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

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