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

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ClinicalTrials.gov Identifier: NCT03354598
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Iterum Therapeutics, International Limited

Brief 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

Condition or disease Intervention/treatment Phase
Uncomplicated Urinary Tract Infections Drug: Sulopenem-Etzadroxil/Probenecid Drug: Ciprofloxacin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of Efficacy, Tolerability, and Safety of Oral Sulopenem-etzadroxil/Probenecid vs Oral Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections in Adult Women
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Cipro




Primary Outcome Measures :
  1. Overall success (combined clinical and microbiological success) in each arm in the micro-MITTS population and in each arm in the micro-MITTR population [ Time Frame: Day 12+/-1 day ]
    Clinical response is defined as complete resolution of uUTI symptoms present at study entry and no new uUTI symptoms; microbiologic success is defined as eradication of the baseline pathogen


Secondary Outcome Measures :
  1. Microbiologic success in each arm in the microbiologically evaluable population [ Time Frame: Day 12+/-1 day ]
    Microbiologic success is defined as eradication of the baseline pathogen (<1000 CFU/mL)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females are eligible for this study.
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03354598


Contacts
Contact: Steve Aronin, MD 860-661-4035 saronin@iterumtx.com

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Sponsors and Collaborators
Iterum Therapeutics, International Limited

Responsible Party: Iterum Therapeutics, International Limited
ClinicalTrials.gov Identifier: NCT03354598     History of Changes
Other Study ID Numbers: IT001-301
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Ciprofloxacin
Lactams
Probenecid
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents