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Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

NCT01345929•Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed Description

Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines).
•2. Be males or females ≥ 18 years of age
•3. If female, subject is non-lactating, and is either:
•1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
•2. Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication.
•4. Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication.
•5. Pyuria (white blood cell \[WBC\] count \> 10/μL in unspun urine or ≥ 10 per high power field in spun urine).
•6. Clinical signs and/or symptoms of cUTI, either of:
•1. Pyelonephritis, as indicated by at least 2 of the following:
•* Documented fever (oral temperature \> 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
+18 more criteria

Exclusion Criteria

•1. Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
•2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity \[e.g., vancomycin, linezolid\] are allowed.)
•3. Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
•4. Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture).
•5. Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy.
•6. Complete, permanent obstruction of the urinary tract.
•7. Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL).
•8. Permanent indwelling bladder catheter or urinary stent including nephrostomy.
•9. Suspected or confirmed perinephric or intrarenal abscess.
•10. Suspected or confirmed prostatitis.
+10 more criteria

Locations (76)

San Diego, California, United States

Wheat Ridge, Colorado, United States

Hialeah, Florida, United States

Teaneck, New Jersey, United States

Charleston, South Carolina, United States

Belo Horizonte, Minas Gerais, Brazil

Porto Alegre, Rio Grande de Sul, Brazil

Joinville, Santa Catarina, Brazil

Campinas, São Paulo, Brazil

Sao Jose de Rio Preto, São Paulo, Brazil

Key Dates

Start Date

June 20, 2011

Primary Completion Date

August 11, 2013

Completion Date

September 4, 2013

Last Updated

October 25, 2018

Enrollment

558

ACTUAL participants

Conditions

Complicated Urinary Tract InfectionPyelonephritis

Interventions

CXA-201

DRUG

Levofloxacin

DRUG

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

NCT04876131

Complicated Urinary Tract InfectionInfection+1 more

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RECRUITINGPHASE2

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

NCT05826990

Complicated Urinary Tract Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Inclusion Criteria

Exclusion Criteria

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

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Factors and Prognosis of Obstructive Pyelonephritis Patients

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Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections