AzTrials
AzTrials

Uncomplicated Urinary Tract InfectionsPhase 3NCT03354598

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

A Phase 3 study testing Sulopenem-Etzadroxil/Probenecid and Ciprofloxacin in people with Uncomplicated Urinary Tract Infections, run by Iterum Therapeutics, International Limited at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uncomplicated Urinary Tract Infections
What is being tested?
Sulopenem-Etzadroxil/Probenecid and Ciprofloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,671 participants
Where
60 sitesUnited States
Study dates
1 Aug 2018to 20 Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
  • Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
  • A mid-stream urine specimen with:
  • a dipstick analysis positive for nitrite AND
  • evidence of pyuria as defined by either:
  • 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
  • Has given written informed consent to participate in the study.

Who cannot join

  • Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
  • Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
  • Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
  • Patients with ileal loops or urinary stoma
  • Patients with an indwelling urinary catheter in the previous 30 days
  • Patients with paraplegia
Show all 25Show fewer
  • Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
  • Any history of trauma to the pelvis or urinary tract
  • 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
  • Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
  • Known history of creatinine clearance <50 mL/min
  • Patients known to have liver disease
  • Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
  • Patients with uncontrolled diabetes mellitus
  • Patients with history of blood dyscrasias
  • Patients with history of uric acid kidney stones
  • Patients with acute gouty attack
  • Patients on chronic methotrexate therapy
  • Patient known to be immunocompromised
  • Patients with a known history of myasthenia gravis
  • Patients who require concomitant administration of tizanidine or valproic acid
  • Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
  • 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
  • History of seizures
  • Use of any other investigational drug in the 30 days prior to the study

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Medical Facility

    Atlanta, Georgia, 30312

  • Medical Facility

    Austin, Texas, 78705

  • Medical Facility

    Austin, Texas, 78735

  • Medical Facility

    Birmingham, Alabama, 35242

  • Medical Facility

    Bountiful, Utah, 84010

  • Medical Facility

    Bradenton, Florida, 34209

  • Medical Facility

    Brooklyn, New York, 11215

  • Medical Facility

    Carrollton, Texas, 75010

  • Medical Facility

    Cerritos, California, 90703

  • Medical Facility

    Chula Vista, California, 91911

  • Medical Facility

    Clearwater, Florida, 33761

  • Medical Facility

    Corpus Christi, Texas, 78414

  • Medical Facility

    Dallas, Texas, 75204

  • Medical Facility

    Doral, Florida, 33166

  • Medical Facility

    Easley, South Carolina, 29640

  • Medical Facility

    Edgewater, Florida, 32132

  • Medical Facility

    Fullerton, California, 92835

  • Medical Facility

    Hialeah, Florida, 33012

  • Medical Facility

    Houston, Texas, 77029

  • Medical Facility

    Houston, Texas, 77036

  • Medical Facility

    Hugo, Oklahoma, 74743

  • Medical Facility

    La Mesa, California, 91942

  • Medical Facility

    Lake Charles, Louisiana, 70601

  • Medical Facility

    Lancaster, South Carolina, 29720

  • Medical Facility

    Las Vegas, Nevada, 89109

  • Medical Facility

    Las Vegas, Nevada, 89121

  • Medical Facility

    Lauderdale Lakes, Florida, 33319

  • Medical Facility

    Los Angeles, California, 90057

  • Medical Facility

    Metairie, Louisiana, 70115

  • Medical Facility

    Miami, Florida, 33126

  • Medical Facility

    Miami, Florida, 33135

  • Medical Facility

    Miami, Florida, 33144

  • Medical Facility

    Miami, Florida, 33145

  • Medical Facility

    Miami, Florida, 33155

  • Medical Facility

    Miami, Florida, 33165

  • Medical Facility

    Miami, Florida, 33172

  • Medical Facility

    Miami, Florida, 33173

  • Medical Facility

    Miami Springs, Florida, 33166

  • Medical Facility

    Myrtle Beach, South Carolina, 29572

  • Medical Facility

    New Orleans, Louisiana, 70115

  • Medical Facility

    New Port Richey, Florida, 34653

  • Medical Facility

    Norcross, Georgia, 30092

  • Medical Facility

    Ormond Beach, Florida, 32174

  • Medical Facility

    Palmetto Bay, Florida, 33157

  • Medical Facility

    Pearland, Texas, 77584

  • Medical Facility

    Perry, Georgia, 31069

  • Medical Facility

    Phoenix, Arizona, 85032

  • Medical Facility

    Plano, Texas, 75024

  • Medical Facility

    Raleigh, North Carolina, 27612

  • Medical Facility

    Salt Lake City, Utah, 84109

  • Medical Facility

    Salt Lake City, Utah, 84121

  • Medical Facility

    San Diego, California, 92108

  • Medical Facility

    South Jordan, Utah, 84095

  • Medical Facility

    St. George, Utah, 84790

  • Medical Facility

    St. Petersburg, Florida, 33711

  • Medical Facility

    Sugar Land, Texas, 77478

  • Medical Facility

    Sylmar, California, 91342

  • Medical Facility

    Tolleson, Arizona, 85353

  • Medical Facility

    Washington D.C., District of Columbia, 20011

  • Medical Facility

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: 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

Being tested
Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulopenem-Etzadroxil/ProbenecidDrug

    Treatment of uncomplicated urinary tract infection

  • CiprofloxacinDrug

    Also called Cipro

    Treatment of uncomplicated urinary tract infection

Study groups in NCT03354598
Study groupRoleWhat they receive
Sulopenem-etzadroxil/probenecidExperimentalSulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
Receives: Drug: Sulopenem-Etzadroxil/Probenecid
CiprofloxacinActive comparatorCiprofloxacin 250 mg PO administered twice daily for 3 days
Receives: Drug: Ciprofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success

    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)

    Measured: Day 12+/-1 day

  2. Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success

    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)

    Measured: Day 12 +/- 1 day

Secondary outcomes (1)

  1. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success

    Microbiologic success is defined as eradication of the baseline pathogen (<1000 Colony Forming Units (CFU)/mL) at the Test of Cure visit

    Measured: Day 12+/-1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2017
  2. Study start1 Aug 2018
  3. Primary completion16 Jan 2020
  4. Study completion20 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354598
Sponsor's protocol ID
IT001-301
Status last verified
Dec 2019
First submitted
20 Nov 2017
Last updated
12 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dunne MW, Aronin SI, Das AF, Akinapelli K, Zelasky MT, Puttagunta S, Boucher HW. Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):66-77. doi: 10.1093/cid/ciac738.

    PubMed 36069202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sulopenem-Etzadroxil/Probenecid and Ciprofloxacin in people with Uncomplicated Urinary Tract Infections, run by Iterum Therapeutics, International Limited at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success (time frame: Day 12+/-1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in