NCT03357614

Brief Summary

This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,395

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_3

Geographic Reach
5 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

November 20, 2017

Results QC Date

November 5, 2020

Last Update Submit

December 3, 2020

Conditions

Complicated Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Overall Success

    Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)

    Day 21 +/- 1 day

Secondary Outcomes (1)

  • Percentage of Participants With Microbiologic Success

    Day 21 +/- 1 day

Study Arms (2)

Sulopenem

EXPERIMENTAL

Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment

Drug: SulopenemDrug: Sulopenem-Etzadroxil/Probenecid

Ertapenem

ACTIVE COMPARATOR

Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment

Drug: ErtapenemDrug: CiprofloxacinDrug: Amoxicillin-clavulanate

Interventions

SulopenemDRUG

Antibiotic therapy for complicated UTI

Sulopenem
Sulopenem-Etzadroxil/ProbenecidDRUG

Antibiotic therapy for complicated UTI

Sulopenem
ErtapenemDRUG

Antibiotic therapy for complicated UTI

Also known as: Invanz
Ertapenem
CiprofloxacinDRUG

Antibiotic therapy for complicated UTI

Also known as: Cipro
Ertapenem
Amoxicillin-clavulanateDRUG

Antibiotic therapy for complicated UTI

Also known as: Augmentin
Ertapenem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI
  • Able to provide informed consent
  • Clinically documented pyelonephritis or complicated urinary tract infection:
  • Pyelonephritis with normal anatomy
  • Complicated UTI as defined by one or more of the following factors:
  • i. The presence of an indwelling catheter ii. \>100 mL of residual urine after voiding iii. Neurogenic bladder iv. Obstructive uropathy due to nephrolithiasis, tumor or fibrosis v. Azotemia due to intrinsic renal disease vi. Urinary retention in men possibly due to benign prostatic hypertrophy vii. Surgically modified or abnormal urinary tract anatomy
  • At least two of the following signs or symptoms:
  • Rigors, chills or fever/hypothermia
  • Flank pain or pelvic pain
  • Nausea or vomiting
  • Dysuria, urinary frequency or urinary urgency
  • Costovertebral angle tenderness on physical examination
  • A mid-stream urine specimen with:
  • a dipstick analysis positive for nitrite AND
  • evidence of pyuria as defined by either: i. a dipstick analysis positive for leukocyte esterase AND/OR ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine AND/OR iii. White blood cell count ≥10 cells/high-powered field in urine sediment

You may not qualify if:

  • Receipt of effective antibacterial drug therapy for complicated urinary tract infection (cUTI) for a continuous duration of more than 24 hours during the previous 72 hours. Patients who have objective documentation of clinical progression of cUTI while on antibacterial drug therapy, or patients who received antibacterial drugs for surgical prophylaxis and then develop cUTI, may be appropriate for enrollment.
  • Subjects with an organism isolated from the urine within the last year known to be resistant to ertapenem
  • Severe structural or functional urinary tract abnormality responsible for an intractable infection which in the opinion of the investigator would require \> 10 days of therapy or post-treatment prophylaxis (eg. patients with chronic vesiculo-ureteral reflux).
  • Uncomplicated UTI
  • Patients with paraplegia/quadriplegia
  • Hypotension with systolic blood pressure \< 90 mm Hg
  • Complicated UTI associated with complete obstruction, emphysematous pyelonephritis, known or suspected renal or perinephric abscess or expected to require surgical intervention (not placement of catheters) to achieve cure
  • Patients with a known history of myasthenia gravis
  • Patients who require concomitant administration of tizanidine or valproic acid
  • Patients with a history of allergy to carbapenems or quinolones or amoxicillin-clavulanate or other beta-lactams, or hypersensitivity to probenecid
  • Renal transplantation
  • Patients requiring dialysis
  • Acute or chronic prostatitis
  • High risk for cUTI caused by Pseudomonas sp. (eg,. history of prior UTI due to Pseudomonas species, recent steroid use, others)
  • Chronic indwelling catheters or stents
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Medical Facility

Bellflower, California, 90706, United States

Location

Medical Facility

Chula Vista, California, 91911, United States

Location

Medical Facility

La Mesa, California, 91942, United States

Location

Medical Facility

La Palma, California, 90623, United States

Location

Medical Facility

Torrance, California, 90502, United States

Location

Medical Facility

Miami Lakes, Florida, 33014, United States

Location

Medical Facility

Columbus, Georgia, 31904, United States

Location

Medical Facility

Idaho Falls, Idaho, 83404, United States

Location

Medical Facility

Boston, Massachusetts, 02111, United States

Location

Medical Facility

Royal Oak, Michigan, 48073, United States

Location

Medical Facility

Butte, Montana, 59701, United States

Location

Medical Facility

Columbus, Ohio, 43214, United States

Location

Medical Facility

Columbus, Ohio, 43215, United States

Location

Medical Facility

Dallas, Texas, 75246, United States

Location

Medical Facility

Houston, Texas, 77057, United States

Location

Medical Facility

Kohtla-Järve, 31025, Estonia

Location

Medical Facility

Tallinn, 10617, Estonia

Location

Medical Facility

Võru, 65526, Estonia

Location

Medical Facility

Tbilisi, 00144, Georgia

Location

Medical Facility

Tbilisi, 00159, Georgia

Location

Medical Facility

Tbilisi, 00160, Georgia

Location

Medical Facility

Baja, 6500, Hungary

Location

Medical Facility

Budapest, 01204, Hungary

Location

Medical Facility

Nagykanizsa, 8800, Hungary

Location

Medical Facility

Nyíregyháza, 4400, Hungary

Location

Medical Facility

Szentes, 06600, Hungary

Location

Medical Facility

Tatabánya, 2800, Hungary

Location

Medical Facility

Daugavpils, LV5417, Latvia

Location

Medical Facility

Liepāja, LV3414, Latvia

Location

Medical Facility

Riga, LV1002, Latvia

Location

Medical Facility

Riga, LV1038, Latvia

Location

Medical Facility

Valmiera, LV4201, Latvia

Location

Related Publications (1)

  • Dunne MW, Aronin SI, Das AF, Akinapelli K, Breen J, Zelasky MT, Puttagunta S. Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):78-88. doi: 10.1093/cid/ciac704.

    PMID: 36068705DERIVED

MeSH Terms

Interventions

sulopenemProbenecidErtapenemCiprofloxacinAmoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsCarbapenemsbeta-LactamsLactamsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesClavulanic AcidClavulanic AcidsAmoxicillinAmpicillinPenicillin GPenicillinsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Senior Director, Clinical Development
Organization
Iterum Therapeutics
saronin@iterumtx.com
18606614035

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 30, 2017

Study Start

September 18, 2018

Primary Completion

December 14, 2019

Study Completion

December 14, 2019

Last Updated

December 29, 2020

Results First Posted

December 29, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)GE(3)US(15)HU(6)LA(5)