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CompletedNCT03445195Updated Jan 22, 2020Results posted

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

A Phase 2 interventional study of Sulbactam-ETX2514 and Placebo in Complicated Urinary Tract Infection and Acute Pyelonephritis, sponsored by Entasis Therapeutics. Completed at 4 sites in Bulgaria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Entasis Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
03

In context

Pyelonephritis

79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.

This study's enrollment of 80 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.

Browse Pyelonephritis studies →

Lead sponsor

Entasis Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A signed 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin

    Drug: Sulbactam-ETX2514 · Drug: Imipenem-cilastatin

  • Placebo comparator
    Placebo + Imipenem/Cilastatin

    Drug: Placebo · Drug: Imipenem-cilastatin

Interventions

  • DrugSulbactam-ETX2514

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

    Also known as: ETX2514SUL

  • DrugPlacebo

    Matching 1g IV solution.

  • DrugImipenem-cilastatin

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

06

What researchers measure

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.

    Time frame: From baseline through day 21

Secondary outcomes

  1. 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.

    Time frame: Baseline to day 21

  2. 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

    Time frame: Baseline to day 21

07

Results

Posted Jun 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneSulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/Cilastatin
Started5327
Completed5127
Not completed20

Outcome measures

PrimaryNumber 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.

Time frame:
From baseline through day 21
Reported as:
Count of participants · Participants
Number of Participants With Overall Success
ParticipantsSulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/Cilastatin
Number of Participants With Overall Success3617
SecondaryClinical 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.

Time frame:
Baseline to day 21
Reported as:
Count of participants · Participants
Clinical Cure
ParticipantsSulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/Cilastatin
MITT population5227
m-MITT population4621
CE population5227
ME population4521
SecondaryMicrobiologic 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

Time frame:
Baseline to day 21
Reported as:
Count of participants · Participants
Microbiologic Eradication
ParticipantsSulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/Cilastatin
m-MITT population3717
ME population3617

Adverse events

Collected over 48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin0/53 (0%)0/53 (0%)8/53 (15.1%)
Placebo + Imipenem/Cilastatin0/27 (0%)0/27 (0%)3/27 (11.1%)
Most frequent other events
Most frequent other events
EventSulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/Cilastatin
HeadacheNervous system disorders5/532/27
PhlebitisVascular disorders3/531/27

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Mean51.4 ± 17.5554.9 ± 15.9252.6 ± 17.00
Sex: Female, Male
Sex: Female, Male(Participants)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Female271138
Male261642
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Hispanic or Latino101
Not Hispanic or Latino522779
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White532780
More than one race000
Unknown or Not Reported000
BMI (Body Mass Index)
BMI (Body Mass Index)(Kg/m^2)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Mean28.09 ± 6.66128.63 ± 5.85628.27 ± 6.368
Height
Height(Centimeters)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Mean172.6 ± 8.81173.1 ± 8.44172.8 ± 8.63
Weight
Weight(Kilograms)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Mean83.79 ± 20.64485.76 ± 17.92984.45 ± 19.677
Screening Creatinine Clearance
Screening Creatinine Clearance(Milliliters per minute)Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/CilastatinPlacebo + Imipenem/CilastatinTotal
Mean94.3 ± 23.7691.7 ± 18.1993.4 ± 21.96
08

Study locations

4 sites
  • Universeity Multiprofile Hospital for Active Teatment
    Sofia, 1431, Bulgaria
  • University Multiprofile Hospital for Active Teatment-Clinic of Nephrology
    Sofia, 1431, Bulgaria
  • Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
    Sofia, 1606, Bulgaria
  • Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie
    Sofia, 1632, Bulgaria
09

References and documents

Publications

  • 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. PubMed 31843995 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03445195
Lead sponsor
Entasis Therapeutics
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jan 17, 2018
Primary completion
May 17, 2018
Completion
May 17, 2018
Results posted
Jun 5, 2019
Last update
Jan 22, 2020

Study contacts

Anibal Calmaggi, MD
study chair · Medpace, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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