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

NCT ID: NCT03445195

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2018-05-17

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.

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

Group Type: EXPERIMENTAL

Sulbactam-ETX2514

Intervention Type: DRUG

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

Imipenem-cilastatin

Intervention Type: DRUG

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

Placebo + Imipenem/Cilastatin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching 1g IV solution.

Imipenem-cilastatin

Intervention Type: DRUG

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

Interventions

Sulbactam-ETX2514

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

Intervention Type: DRUG

Placebo

Matching 1g IV solution.

Intervention Type: DRUG

Imipenem-cilastatin

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

Intervention Type: DRUG

Other Intervention Names

ETX2514SUL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entasis Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anibal Calmaggi, MD

Role: STUDY_CHAIR

Medpace, Inc.

Locations

Universeity Multiprofile Hospital for Active Teatment

Sofia, , Bulgaria

University Multiprofile Hospital for Active Teatment-Clinic of Nephrology

Sofia, , Bulgaria

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

Sofia, , Bulgaria

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

Sofia, , Bulgaria

Countries

Bulgaria

References

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.

Reference Type: DERIVED

PMID: 31843995 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CS2514-2017-0003

Identifier Type: -

Identifier Source: org_study_id