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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulopenem-etzadroxil/probenecid | Experimental | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days |
|
| Ciprofloxacin | Active Comparator | Ciprofloxacin 250 mg PO administered twice daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulopenem-Etzadroxil/Probenecid | Drug | Treatment of uncomplicated urinary tract infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 12+/-1 day |
| 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) | Day 12 +/- 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 12+/-1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) 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) | 12 +/- 1 day |
Inclusion Criteria:
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:
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
Has given written informed consent to participate in the study.
Exclusion Criteria:
Only females are eligible for this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility | Birmingham | Alabama | 35242 | United States | ||
| Medical Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36069202 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulopenem-etzadroxil/Probenecid | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection |
| FG001 | Ciprofloxacin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2018 | Nov 20, 2020 |
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| Ciprofloxacin | Drug | Treatment of uncomplicated urinary tract infection |
|
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Medical Facility | Tolleson | Arizona | 85353 | United States |
| Medical Facility | Cerritos | California | 90703 | United States |
| Medical Facility | Chula Vista | California | 91911 | United States |
| Medical Facility | Fullerton | California | 92835 | United States |
| Medical Facility | La Mesa | California | 91942 | United States |
| Medical Facility | Los Angeles | California | 90057 | United States |
| Medical Facility | San Diego | California | 92108 | United States |
| Medical Facility | Sylmar | California | 91342 | United States |
| Medical Facility | Washington D.C. | District of Columbia | 20011 | United States |
| Medical Facility | Bradenton | Florida | 34209 | United States |
| Medical Facility | Clearwater | Florida | 33761 | United States |
| Medical Facility | Doral | Florida | 33166 | United States |
| Medical Facility | Edgewater | Florida | 32132 | United States |
| Medical Facility | Hialeah | Florida | 33012 | United States |
| Medical Facility | Lauderdale Lakes | Florida | 33319 | United States |
| Medical Facility | Miami | Florida | 33126 | United States |
| Medical Facility | Miami | Florida | 33135 | United States |
| Medical Facility | Miami | Florida | 33144 | United States |
| Medical Facility | Miami | Florida | 33145 | United States |
| Medical Facility | Miami | Florida | 33155 | United States |
| Medical Facility | Miami | Florida | 33165 | United States |
| Medical Facility | Miami | Florida | 33172 | United States |
| Medical Facility | Miami | Florida | 33173 | United States |
| Medical Facility | Miami Springs | Florida | 33166 | United States |
| Medical Facility | New Port Richey | Florida | 34653 | United States |
| Medical Facility | Ormond Beach | Florida | 32174 | United States |
| Medical Facility | Palmetto Bay | Florida | 33157 | United States |
| Medical Facility | St. Petersburg | Florida | 33711 | United States |
| Medical Facility | Winter Haven | Florida | 33880 | United States |
| Medical Facility | Atlanta | Georgia | 30312 | United States |
| Medical Facility | Norcross | Georgia | 30092 | United States |
| Medical Facility | Perry | Georgia | 31069 | United States |
| Medical Facility | Lake Charles | Louisiana | 70601 | United States |
| Medical Facility | Metairie | Louisiana | 70115 | United States |
| Medical Facility | New Orleans | Louisiana | 70115 | United States |
| Medical Facility | Las Vegas | Nevada | 89109 | United States |
| Medical Facility | Las Vegas | Nevada | 89121 | United States |
| Medical Facility | Brooklyn | New York | 11215 | United States |
| Medical Facility | Raleigh | North Carolina | 27612 | United States |
| Medical Facility | Hugo | Oklahoma | 74743 | United States |
| Medical Facility | Easley | South Carolina | 29640 | United States |
| Medical Facility | Lancaster | South Carolina | 29720 | United States |
| Medical Facility | Myrtle Beach | South Carolina | 29572 | United States |
| Medical Facility | Austin | Texas | 78705 | United States |
| Medical Facility | Austin | Texas | 78735 | United States |
| Medical Facility | Carrollton | Texas | 75010 | United States |
| Medical Facility | Corpus Christi | Texas | 78414 | United States |
| Medical Facility | Dallas | Texas | 75204 | United States |
| Medical Facility | Houston | Texas | 77029 | United States |
| Medical Facility | Houston | Texas | 77036 | United States |
| Medical Facility | Pearland | Texas | 77584 | United States |
| Medical Facility | Plano | Texas | 75024 | United States |
| Medical Facility | Sugar Land | Texas | 77478 | United States |
| Medical Facility | Bountiful | Utah | 84010 | United States |
| Medical Facility | Salt Lake City | Utah | 84109 | United States |
| Medical Facility | Salt Lake City | Utah | 84121 | United States |
| Medical Facility | South Jordan | Utah | 84095 | United States |
| Medical Facility | St. George | Utah | 84790 | United States |
Ciprofloxacin 250 mg PO administered twice daily for 3 days
Ciprofloxacin: Treatment of uncomplicated urinary tract infection
| Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants |
|
| Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants |
|
| Microbiologic Modified Intent to Treat (Micro-MITT) Participants |
|
| Modified Intent to Treat (MITT) Participants |
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| Intent to Treat (ITT) Participants |
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| Safety Participants |
|
| COMPLETED |
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| NOT COMPLETED |
|
Intent to Treat (ITT) Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulopenem-etzadroxil/Probenecid | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection |
| BG001 | Ciprofloxacin | Ciprofloxacin 250 mg PO administered twice daily for 3 days Ciprofloxacin: Treatment of uncomplicated urinary tract infection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | micro-MITTR population: patients with baseline uropathogen non-susceptible to the comparator ciprofloxacin. | Posted | Number | percentage of participants | Day 12+/-1 day |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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) | micro-MITTS population: patients with baseline uropathogen susceptible to the comparator ciprofloxacin. | Posted | Number | percentage of participants | Day 12 +/- 1 day |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | micro-MITTR population: patients with baseline uropathogen non-susceptible to the comparator ciprofloxacin. | Posted | Number | percentage of participants | Day 12+/-1 day |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) 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) | micro-MITT population: micro-MITTR and micro-MITTS (ciprofloxacin nonsusceptible and ciprofloxacin susceptible) populations combined. | Posted | Number | percentage of participants | 12 +/- 1 day |
|
|
From the time of informed consent through the final visit, an average of 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulopenem-etzadroxil/Probenecid | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection | 1 | 833 | 6 | 833 | 103 | 833 |
| EG001 | Ciprofloxacin | Ciprofloxacin 250 mg PO administered twice daily for 3 days Ciprofloxacin: Treatment of uncomplicated urinary tract infection | 0 | 827 | 2 | 827 | 21 | 827 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| small intestine obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| pyelonephritis acute | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| urosepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| presuncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| angioedema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
The PI will provide Iterum opportunity to review proposed publication/other type of disclosure before submitted/disclosed. PI will provide full text of intended disclosure to Iterum at least 30 days before submitted/disclosed. If any patent action is required to protect intellectual property rights, PI agrees to delay disclosure for a period not to exceed an additional 60 days. PI will, on request, remove previously undisclosed Confidential Information before disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Development | Iterum Therapeutics | 18606614035 | saronin@iterumtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2020 | Nov 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011339 | Probenecid |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Ukraine |
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| Russia |
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