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

NCT03445195 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CS2514-2017-0003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline through day 21

Secondary Outcomes (2)

• Clinical Cure

  Baseline to day 21

• Microbiologic Eradication

  Baseline to day 21

Study Arms (2)

Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

EXPERIMENTAL

Drug: Sulbactam-ETX2514; Drug: Imipenem-cilastatin

Placebo + Imipenem/Cilastatin

PLACEBO COMPARATOR

Drug: Placebo; Drug: Imipenem-cilastatin

Interventions

Sulbactam-ETX2514 DRUG

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

Also known as: ETX2514SUL

Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

Placebo DRUG

Matching 1g IV solution.

Placebo + Imipenem/Cilastatin

Imipenem-cilastatin DRUG

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

Placebo + Imipenem/Cilastatin; Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Entasis Therapeutics: lead

Study Sites (4)

Universeity Multiprofile Hospital for Active Teatment

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Teatment-Clinic of Nephrology

Sofia, 1431, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

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

Sofia, 1632, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 31843995 DERIVED

MeSH Terms

Interventions

Cilastatin, Imipenem Drug Combination

Intervention Hierarchy (Ancestors)

Imipenem; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Entasis Therapeutics

Enquiries@entasistx.com

781-810-8940

Study Officials

• Anibal Calmaggi, MD

  Medpace, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: January 17, 2018
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: January 22, 2020
• Results First Posted: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (4)