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Last Updated: April 26, 2024

CLINICAL TRIALS PROFILE FOR SULOPENEM

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Clinical Trials for Sulopenem

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00759564 ↗	A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function	Completed	Pfizer	Phase 1	This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).
NCT00797108 ↗	A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization	Completed	Pfizer	Phase 2	The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, International Limited	Phase 3	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
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, US Limited	Phase 3	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
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, International Limited	Phase 3	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.
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, US Limited	Phase 3	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 ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for Sulopenem

Condition Name

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Condition Name for
Intervention	Trials
Urinary Tract Infections	4
Antibiotic Resistant Infection	3
Complicated Infection	2
Intra Abdominal Infections	1
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Condition MeSH

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Condition MeSH for
Intervention	Trials
Communicable Diseases	5
Infection	4
Urinary Tract Infections	4
Infections	4
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Clinical Trial Locations for Sulopenem

Trials by Country

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Trials by Country for
Location	Trials
United States	55
Hungary	2
Georgia	2
Poland	2
Estonia	2
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Trials by US State

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Trials by US State for
Location	Trials
California	5
Ohio	4
Montana	3
Idaho	3
Texas	3
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Clinical Trial Progress for Sulopenem

Clinical Trial Phase

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Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1	2
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Clinical Trial Status

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Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	2
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Clinical Trial Sponsors for Sulopenem

Sponsor Name

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Sponsor Name for
Sponsor	Trials
Iterum Therapeutics, International Limited	5
Iterum Therapeutics, US Limited	3
Pfizer	2
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Sponsor Type

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Sponsor Type for
Sponsor	Trials
Industry	10
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