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

Acute Pyelonephritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445195
• Other study ID #: CS2514-2017-0003
• Status: Completed
• Phase: Phase 2
• Start date: January 17, 2018
• Est. completion date: May 17, 2018

Study information

• Verified date: June 2019
• Source: Entasis Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Communicable Diseases
• Complicated Urinary Tract Infection
• Infection
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• Sulbactam-ETX2514
The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
• Placebo
Matching 1g IV solution.
• Imipenem-cilastatin
All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie	Sofia
Bulgaria	Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov	Sofia
Bulgaria	Universeity Multiprofile Hospital for Active Teatment	Sofia
Bulgaria	University Multiprofile Hospital for Active Teatment-Clinic of Nephrology	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Entasis Therapeutics

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to day 21
Secondary	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	Baseline to day 21