Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

December 17, 2020 updated by: Iterum Therapeutics, International Limited

A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1671

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Medical facility
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Medical facility
      • Tolleson, Arizona, United States, 85353
        • Medical facility
    • California
      • Cerritos, California, United States, 90703
        • Medical facility
      • Chula Vista, California, United States, 91911
        • Medical facility
      • Fullerton, California, United States, 92835
        • Medical facility
      • La Mesa, California, United States, 91942
        • Medical facility
      • Los Angeles, California, United States, 90057
        • Medical facility
      • San Diego, California, United States, 92108
        • Medical facility
      • Sylmar, California, United States, 91342
        • Medical facility
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Medical facility
    • Florida
      • Bradenton, Florida, United States, 34209
        • Medical facility
      • Clearwater, Florida, United States, 33761
        • Medical facility
      • Doral, Florida, United States, 33166
        • Medical facility
      • Edgewater, Florida, United States, 32132
        • Medical facility
      • Hialeah, Florida, United States, 33012
        • Medical facility
      • Lauderdale Lakes, Florida, United States, 33319
        • Medical facility
      • Miami, Florida, United States, 33144
        • Medical facility
      • Miami, Florida, United States, 33126
        • Medical facility
      • Miami, Florida, United States, 33135
        • Medical facility
      • Miami, Florida, United States, 33145
        • Medical facility
      • Miami, Florida, United States, 33155
        • Medical facility
      • Miami, Florida, United States, 33165
        • Medical facility
      • Miami, Florida, United States, 33172
        • Medical facility
      • Miami, Florida, United States, 33173
        • Medical facility
      • Miami Springs, Florida, United States, 33166
        • Medical facility
      • New Port Richey, Florida, United States, 34653
        • Medical facility
      • Ormond Beach, Florida, United States, 32174
        • Medical facility
      • Palmetto Bay, Florida, United States, 33157
        • Medical facility
      • Saint Petersburg, Florida, United States, 33711
        • Medical facility
      • Winter Haven, Florida, United States, 33880
        • Medical facility
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Medical facility
      • Norcross, Georgia, United States, 30092
        • Medical facility
      • Perry, Georgia, United States, 31069
        • Medical facility
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Medical facility
      • Metairie, Louisiana, United States, 70115
        • Medical facility
      • New Orleans, Louisiana, United States, 70115
        • Medical facility
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Medical facility
      • Las Vegas, Nevada, United States, 89121
        • Medical facility
    • New York
      • Brooklyn, New York, United States, 11215
        • Medical facility
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Medical facility
    • Oklahoma
      • Hugo, Oklahoma, United States, 74743
        • Medical facility
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Medical facility
      • Lancaster, South Carolina, United States, 29720
        • Medical facility
      • Myrtle Beach, South Carolina, United States, 29572
        • Medical facility
    • Texas
      • Austin, Texas, United States, 78705
        • Medical facility
      • Austin, Texas, United States, 78735
        • Medical facility
      • Carrollton, Texas, United States, 75010
        • Medical facility
      • Corpus Christi, Texas, United States, 78414
        • Medical facility
      • Dallas, Texas, United States, 75204
        • Medical facility
      • Houston, Texas, United States, 77029
        • Medical facility
      • Houston, Texas, United States, 77036
        • Medical facility
      • Pearland, Texas, United States, 77584
        • Medical facility
      • Plano, Texas, United States, 75024
        • Medical facility
      • Sugar Land, Texas, United States, 77478
        • Medical facility
    • Utah
      • Bountiful, Utah, United States, 84010
        • Medical facility
      • Saint George, Utah, United States, 84790
        • Medical facility
      • Salt Lake City, Utah, United States, 84109
        • Medical facility
      • Salt Lake City, Utah, United States, 84121
        • Medical facility
      • South Jordan, Utah, United States, 84095
        • Medical facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
  2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain

  3. A mid-stream urine specimen with:

    1. a dipstick analysis positive for nitrite AND
    2. evidence of pyuria as defined by either:

    i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine

  4. Has given written informed consent to participate in the study.

Exclusion Criteria:

  1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
  2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
  3. Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
  4. Patients with ileal loops or urinary stoma
  5. Patients with an indwelling urinary catheter in the previous 30 days
  6. Patients with paraplegia
  7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
  8. Any history of trauma to the pelvis or urinary tract
  9. Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
  10. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
  11. Known history of creatinine clearance <50 mL/min
  12. Patients known to have liver disease
  13. Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
  14. Patients with uncontrolled diabetes mellitus
  15. Patients with history of blood dyscrasias
  16. Patients with history of uric acid kidney stones
  17. Patients with acute gouty attack
  18. Patients on chronic methotrexate therapy
  19. Patient known to be immunocompromised
  20. Patients with a known history of myasthenia gravis
  21. Patients who require concomitant administration of tizanidine or valproic acid
  22. Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
  23. Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
  24. History of seizures
  25. Use of any other investigational drug in the 30 days prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sulopenem-etzadroxil/probenecid
Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
Drug: Sulopenem-Etzadroxil/Probenecid
Treatment of uncomplicated urinary tract infection
Active Comparator: Ciprofloxacin
Ciprofloxacin 250 mg PO administered twice daily for 3 days
Drug: Ciprofloxacin
Treatment of uncomplicated urinary tract infection
Other Names:
  • Cipro

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
Time Frame: Day 12+/-1 day
Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Time Frame: Day 12 +/- 1 day
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Day 12 +/- 1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success
Time Frame: Day 12+/-1 day
Microbiologic success is defined as eradication of the baseline pathogen (<1000 Colony Forming Units (CFU)/mL) at the Test of Cure visit
Day 12+/-1 day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success
Time Frame: 12 +/- 1 day
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
12 +/- 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iterum Therapeutics, International Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IT001-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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