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Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (REASSURE)

Primary Purpose

Urinary Tract Infections, Cystitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sulopenem etzadroxil/probenecid
Amoxicillin/clavulanate
Sponsored by
Iterum Therapeutics, International Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
  • Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
  • A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine

Exclusion Criteria:

  • Presence of signs and symptoms suggestive of acute pyelonephritis defined as: 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, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
  • Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
  • Ongoing urinary retention
  • Neurogenic bladder
  • Current resident of a long-term care facility
  • Instrumentation of urinary tract in the previous 30 days
  • An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
  • Any history of trauma to the pelvis or urinary tract
  • Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
  • History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sulopenem etzadroxil/probenecid

Amoxicillin/clavulanate

Arm Description

Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days

Amoxicillin/clavulanate PO twice daily for 5 days

Outcomes

Primary Outcome Measures

Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) 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)
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) 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)
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)

Secondary Outcome Measures

Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen)
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Asymptomatic Bacteriuria
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Asymptomatic Bacteriuria
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success
Microbiologic Success: Eradication of the Baseline Pathogen
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success
Microbiologic Success: Eradication of the Baseline Pathogen
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic Success
Microbiologic Success: Eradication of the Baseline Pathogen

Full Information

First Posted
October 14, 2022
Last Updated
October 12, 2023
Sponsor
Iterum Therapeutics, International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05584657
Brief Title
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Acronym
REASSURE
Official Title
A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iterum Therapeutics, International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
IT001-310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
Detailed Description
IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1966 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sulopenem etzadroxil/probenecid
Arm Type
Experimental
Arm Description
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Arm Title
Amoxicillin/clavulanate
Arm Type
Active Comparator
Arm Description
Amoxicillin/clavulanate PO twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Sulopenem etzadroxil/probenecid
Other Intervention Name(s)
Oral sulopenem
Intervention Description
Oral sulopenem twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/clavulanate
Other Intervention Name(s)
Augmentin
Intervention Description
Oral Augmentin twice daily for 5 days
Primary Outcome Measure Information:
Title
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success
Description
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)
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Description
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)
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
Description
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)
Time Frame
Day 12+/-1 day
Secondary Outcome Measure Information:
Title
Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success
Description
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success
Description
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success
Description
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success
Description
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria
Description
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen)
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Asymptomatic Bacteriuria
Description
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Asymptomatic Bacteriuria
Description
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success
Description
Microbiologic Success: Eradication of the Baseline Pathogen
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success
Description
Microbiologic Success: Eradication of the Baseline Pathogen
Time Frame
Day 12+/-1 day
Title
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic Success
Description
Microbiologic Success: Eradication of the Baseline Pathogen
Time Frame
Day 12+/-1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain. A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine Exclusion Criteria: Presence of signs and symptoms suggestive of acute pyelonephritis defined as: 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, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products. Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis Ongoing urinary retention Neurogenic bladder Current resident of a long-term care facility Instrumentation of urinary tract in the previous 30 days An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract Any history of trauma to the pelvis or urinary tract Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Aronin, MD
Phone
860-661-4035
Email
saronin@iterumtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sailaja Puttagunta, MD
Organizational Affiliation
Iterum Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Medical Facility
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility3
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility 2
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Pomona
State/Province
California
ZIP/Postal Code
91768
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33909
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33460
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33056
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility3
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility9
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility5
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility8
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility6
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility7
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility4
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Orlando
State/Province
Florida
ZIP/Postal Code
32812
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility3
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility4
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility5
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility3
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
08340
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility2
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Schenectady
State/Province
New York
ZIP/Postal Code
12304
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility2
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility2
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lima
State/Province
Ohio
ZIP/Postal Code
45805
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Powdersville
State/Province
South Carolina
ZIP/Postal Code
29611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29678
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility2
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75209
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Georgetown
State/Province
Texas
ZIP/Postal Code
79628
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility2
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility 2
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Facility3
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility 2
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

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