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Trial record 1 of 1 for:    NCT03445195
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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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ClinicalTrials.gov Identifier: NCT03445195
Recruitment Status : Completed
First Posted : February 26, 2018
Results First Posted : June 5, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Entasis Therapeutics

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.

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infection Acute Pyelonephritis Drug: Sulbactam-ETX2514 Drug: Placebo Drug: Imipenem-cilastatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : May 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin Drug: Sulbactam-ETX2514
The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Other Name: ETX2514SUL

Drug: Imipenem-cilastatin
All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Placebo Comparator: Placebo + Imipenem/Cilastatin Drug: Placebo
Matching 1g IV solution.

Drug: Imipenem-cilastatin
All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.




Primary Outcome Measures :
  1. Number of Participants With Overall Success [ Time Frame: From baseline through day 21 ]
    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 :
  1. Clinical Cure [ Time Frame: Baseline to day 21 ]
    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.

  2. Microbiologic Eradication [ Time Frame: Baseline to day 21 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445195


Locations
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Bulgaria
Universeity Multiprofile Hospital for Active Teatment
Sofia, Bulgaria, 1431
University Multiprofile Hospital for Active Teatment-Clinic of Nephrology
Sofia, Bulgaria, 1431
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
Sofia, Bulgaria, 1606
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie
Sofia, Bulgaria, 1632
Sponsors and Collaborators
Entasis Therapeutics
Investigators
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Study Chair: Anibal Calmaggi, MD Medpace, Inc.
  Study Documents (Full-Text)

Documents provided by Entasis Therapeutics:
Study Protocol  [PDF] August 1, 2017
Statistical Analysis Plan  [PDF] April 26, 2018


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Responsible Party: Entasis Therapeutics
ClinicalTrials.gov Identifier: NCT03445195     History of Changes
Other Study ID Numbers: CS2514-2017-0003
First Posted: February 26, 2018    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Imipenem
Sulbactam
Cilastatin, Imipenem Drug Combination
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors